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101. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Plomgaard, Anne M, Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, Plomgaard, Anne M, Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Greisen, Gorm

Abstract

AIM: Cerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age.METHODS: In 2012-2013, the phase II randomised Safeguarding the Brains of our smallest Children trial compared visible cerebral near-infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group. Cerebral hypoxia was significantly reduced in the intervention group. We followed up 115 survivors from eight European centres at two years of corrected age, by conducting a medical examination and assessing their neurodevelopment with the Bayley Scales of Infant and Toddler Development, Second or Third Edition, and the parental Ages and Stages Questionnaire (ASQ).RESULTS: There were no differences between the intervention (n = 65) and control (n = 50) groups with regard to the mean mental developmental index (89.6 ± 19.5 versus 88.4 ± 14.7, p = 0.77), ASQ score (215 ± 58 versus 213 ± 58, p = 0.88) and the number of children with moderate-to-severe neurodevelopmental impairment (10 versus six, p = 0.58).CONCLUSION: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.

Published
2019

102. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Arts-assistenten Kinderen, MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, Arts-assistenten Kinderen, MS Neonatologie, Child Health, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Greisen, Gorm

Published
2019

105. Translating Neurodevelopmental Care Policies Into Practice: The Experience of Neonatal ICUs in France—The EPIPAGE-2 Cohort Study

Author

Pierrat, Veronique, Coquelin, Anaëlle, Cuttini, Marina, Khoshnood, Babak, Glorieux, Isabelle, Claris, Olivier, Durox, Mélanie, Kaminski, Monique, Ancel, Pierre-Yves, and Arnaud, Catherine

Subjects
neurodevelopmental care, Infant, Newborn, Infant, Premature, Diseases, kangaroo care, Kangaroo-Mother Care Method, Neonatal Intensive Care, Breast Feeding, Child Development, Logistic Models, preterm neonate, Neurodevelopmental Disorders, breast-feeding, Intensive Care Units, Neonatal, Practice Guidelines as Topic, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, cohort study, Intensive Care, Neonatal, Humans, France, Prospective Studies, Infant, Premature
Abstract

Supplemental Digital Content is available in the text., Objectives: To describe the implementation of neurodevelopmental care for newborn preterm infants in neonatal ICUs in France in 2011, analyze changes since 2004, and investigate factors associated with practice. Design: Prospective national cohort study of all births before 32 weeks of gestation. Setting: Twenty-five French regions. Participants: All neonatal ICUs (n = 66); neonates surviving at discharge (n = 3,005). Interventions: None. Measurements and Main Results: Neurodevelopmental care policies and practices were assessed by structured questionnaires. Proportions of neonates initiating kangaroo care during the first week of life and those whose mothers expressed breast milk were measured as neurodevelopmental care practices. Multilevel logistic regression analyses were used to investigate relationships between kangaroo care or breast-feeding practices and unit policies, taking into account potential confounders. Free visiting policies, bed availability for parents, and kangaroo care encouragement significantly improved between 2004 and 2011 but with large variabilities between units. Kangaroo care initiation varied from 39% for neonates in the most restrictive units to 68% in less restrictive ones (p < 0.001). Individual factors associated with kangaroo care initiation were gestational age (odds ratio, 5.79; 95% CI, 4.49–7.48 for babies born at 27–31 wk compared with babies born at 23–26 wk) and, to a lesser extent, single pregnancy, birthweight above the 10th centile, and mother’s employment before pregnancy. At unit level, policies and training in neurodevelopmental care significantly influenced kangaroo care initiation (odds ratio, 3.5; 95% CI, 1.8–7.0 for Newborn Individualized Developmental Care and Assessment Program implementation compared with no training). Breast milk expression by mothers was greater in units with full-time availability professionals trained for breast-feeding support (60% vs 73%; p < 0.0001). Conclusions: Dissemination of neurodevelopmental practices occurred between 2004 and 2011, but large variabilities between units persist. Practices increased in units with supportive policies. Specific neurodevelopmental care training with multifaceted interventions strengthened the implementation of policies.

Published
2016

109. Activity report of the VRS study group in Lyon (10.2018)

Author

Jean-Sebastien Casalegno, Lyon, The VRS Study Group In, Benchaib, Mehdi, Yahia Mekki, Gillet, Yves, Vanhems, Philippe, Gaucherand, Pascal, Lina, Bruno, Javouhey, Etienne, Duclos, Antoine, Morfin, Florence, Kramer, Rolf, Claris, Olivier, Valette, Martine, Etienne, Jerome, and Massardier, Jerome

Published
2018
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112. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC randomised clinical phase III trial

Author

Hansen, Mathias, primary, Pellicer, Adelina, additional, Gluud, Christian, additional, Dempsey, Eugene, additional, Mintzer, Jonathan, additional, Hyttel-Sørensen, Simon, additional, Heuchan, Anne Marie, additional, Hagmann, Cornelia, additional, Ergenekon, Ebru, additional, Dimitriou, Gabriel, additional, Pichler, Gerhard, additional, Naulaers, Gunnar, additional, Cheng, Guoqiang, additional, Guimarães, Hercilia, additional, Tkaczyk, Jakub, additional, Kreutzer, Karen B., additional, Fumagalli, Monica, additional, Claris, Olivier, additional, Lemmers, Petra, additional, Fredly, Siv, additional, Szczapa, Tomasz, additional, Austin, Topun, additional, Jakobsen, Janus Christian, additional, and Greisen, Gorm, additional

Published
2019
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114. Three Consecutive Pregnancies in a Patient with Chronic Autoimmune Thyroid Disease Associated with Hypothyroidism and Extremely High Levels of Anti-Thyrotropin Receptor Antibodies

Author

Grulet, Hervé, primary, Barraud, Sara, additional, Chikh, Karim, additional, Souchon, Pierre François, additional, Claris, Olivier, additional, Bouvier, Raymonde, additional, Trouillas, Jacqueline, additional, Gabriel, René, additional, Bory, Jean Paul, additional, Schvartz, Claire, additional, Orgiazzi, Jacques, additional, and Delemer, Brigitte, additional

Published
2019
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115. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC phase III randomized clinical trial

Author

Hansen, Mathias, primary, Pellicer, Adelina, additional, Gluud, Christian, additional, Dempsey, Eugene, additional, Mintzer, Jonathan, additional, Hyttel-Sørensen, Simon, additional, Heuchan, Anne Marie, additional, Hagmann, Cornelia, additional, Ergenekon, Ebru, additional, Dimitriou, Gabriel, additional, Pichler, Gerhard, additional, Naulaers, Gunnar, additional, Cheng, Guoqiang, additional, Guimarães, Hercilia, additional, Tkaczyk, Jakub, additional, Kreutzer, Karen B., additional, Fumagalli, Monica, additional, Claris, Olivier, additional, Lemmers, Petra, additional, Fredly, Siv, additional, Szczapa, Tomasz, additional, Austin, Topun, additional, Jakobsen, Janus Christian, additional, and Greisen, Gorm, additional

Published
2019
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118. Reference values for the external genitalia of full-term and pre-term female neonates.

Author

Castets, Sarah, Nguyen, Kim-An, Plaisant, Franck, Prudon, Malika Baya, Plotton, Ingrid, Kassai, Behrouz, Roche, Sylvain, Ecochard, Rene, Claris, Olivier, Nicolino, Marc, Villanueva, Carine, and Gay, Claire-Lise

Subjects
NEWBORN infants, GENITALIA, GONADAL dysgenesis, REFERENCE values, PREMATURE infants, STEROIDOGENIC acute regulatory protein, VULVA, ADRENAL diseases, ANUS, GESTATIONAL age, BIRTH weight, LONGITUDINAL method
Abstract

Background and Objectives: Identifying virilisation of the genitalia in female newborns early during the neonatal period is important to diagnose pathologies. However, there is no clear threshold for clitoromegaly or for the anogenital ratio. The objective of this study was to define reference values for the external genitalia of full-term and pre-term female neonates.Design: This was a prospective study of all females born in the study centre between May 2014 and July 2016. Clitoral length and anogenital ratio were measured in 619 newborns with a gestational age of 24+2 to 41+3 weeks during their first 3 days of life. Associations between the values at day 3 and gestational age, birth weight and other newborn characteristics were examined by linear regression.Results: The mean clitoral length at day 3 of life was 3.69±1.53 mm (n=551; 95th percentile, 6.5 mm; maximum, 8 mm), and the mean anogenital ratio was 0.42±0.09 (95th percentile, 0.58). There was no significant variation with gestational age or birth weight, and no significant difference between the results at day 0 and day 3.Conclusion: These results suggest that clitoromegaly can be defined as a clitoral length >6.5 mm. Values ≥8 mm should prompt further investigations. An anogenital ratio >0.6 should be considered a sign of virilisation. Since clitoral size does not vary with gestational age or birth weight, clitoromegaly should not be attributed to prematurity. [ABSTRACT FROM AUTHOR]

Published
2021
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119. Nouveau-nés cathétérisés : types de cathéters, risques et bonnes pratiques

Author

Butin, Marine and Claris, Olivier

Subjects
INFECTION ASSOCIÉE AUX SOINS, NOUVEAU-NÉ, NÉONATOLOGIE, CATHÉTER, INFECTION DU CATHÉTER
Abstract

L’utilisation de cathéters veineux, périphériques et centraux est très répandue dans les services de réanimation néonatale et est indispensable pour optimiser la prise en charge des nouveau-nés les plus vulnérables. Plusieurs types de voies centrales sont possibles : cathétérisme de la veine ombilicale, ponction d’un gros vaisseau, ou abord épicutanéocave. Néanmoins l’utilisation d’un cathéter expose le nouveau-né à un certain nombre de complications. Les voies veineuses périphériques peuvent diffuser localement et être à l’origine de lésions cutanées parfois sévères. Par ailleurs les voies centrales sont directement impliquées dans la plupart des infections bactériémiques nosocomiales, notamment chez les nouveau-nés prématurés. De plus ces voies veineuses peuvent provoquer des épanchements péricardiques, pleuraux ou des lésions du foie, notamment si elles sont mal positionnées. Ces différentes complications doivent être mises en balance avec le bénéfice attendu du cathéter, afin de toujours bien peser l’indication de pose et de maintien du cathéter chez un patient donné. Les objectifs de cet article sont de présenter les différents modes de cathétérisme en néonatologie et d’exposer les complications possibles ainsi que les règles de bonnes pratiques d’utilisation de ces cathéters.

Published
2017
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120. Neurodevelopmental Outcomes after Premedication with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial

Author

Lucile, Barcat, Sophie, Boddaert, Evelyne, Caron-Lesenechal, Eléonore, Carpentier, Christèle, Chazal, Mickaël, Delaunay, Coralie, Degorre, Cécile, Fontaine, Laurent, Ghyselen, Sabrina, Goudjil, Guy, Kongolo, André, Leke, François, Moreau, Yasser, Moussa, Isabelle, Popov, GhostineGhida, Ramadan, Lucie, Razafimanantsoa, Bernard, Romeo, Leila, Tellai, Latif, Adamon, Mélanie, Alexandre, Antoine, Alix, Anne, Bellot, Julien, Crosse, Valérie, Dorriere, Marie-Gabrielle, Guillemin, Bernard, Guillois, Mathilde, Leport, Maud, Panici, Da Costa Nathalina, Pinto, Delphine, Rots, Baptiste, Savey, Anne-Sophie, Trentesaux, Barbara, Azcona, Marjorie, Bacher, Emilie, Boiron, Laura, Bourgoin, Firas, Bouafif, Maxime, Brussieux, Laurence, Caeymaex, Sonia, Dahan, Claude, Danan, Gilles, Dassieu, Audrey, Dassy, Fabrice, Decobert, Hélène, Henri, Diane, Jourdan, Inès, Layouni, Morgane, Le Gouez, Elodie, Merlot, Estelle, Millot, Anne, Peluchon, Lanto, Ratsimbazafy, Anais, Renault, Judith, CRA, Toure, Meryl, Vedrenne-Cloquet, Bouthaina, Younes, Huu Kim, An Chu, Anne, Beissel, Karine, Bellemin, Sébastien, Blanc, Hocine, Bouamari, Valentine, Breant, Lydie, Bruschet, Catherine, Clamadieu, Elise, Cornaton, Xavier, Cottin, Muriel, Cudel, Hélène, Gauthier-Moulinier, Franck, Plaisant, Malika, Prudon, Camille, Arberet, Alain, Beuchee, Jennifer, Chauvel, Séverine, Delahaye, Anne-Laure, Deniau, Théophile, Gaillot, Carine, Lallemant, Anne-Marie, Lamour, Fanny, Lebas, Céline, Noseda, Bruno, Ozanne, Patrick, Pladys, Anne, Sauret, de La Pintiere Armelle, Thomas, Olivier, Tirel, Antoine, Bouissou, Sylvain, Cantagrel, Julie, Chantreuil, Aliette, Decock-Giraudaud, François, Labarthe, Véronique, Meteier, Karine, Norbert, Thierry, Perez, Déborah, Planchenault, Nicolas, Roullet, Elie, Saliba, Anne-Laure, Suc, Corinne, eToulouse: Alberge, Romain, Amadieu, Françoise, Auriol, CRA, Senior, Lionel, Berthomieu, Marie-Claude, Bloom, Frédéric, Eyvrard, Martine, Gineste, Camille, Jurado, Isabelle, Kieffer, Sandrine, Lelong, Marie-Odile, Marcoux, Marianne, Mus, Sonia, Pelluau, Mabel, Gaba, Amelle, Issa, Sandrine, Lacour, Stéphane, Bechet, Michel, Boucherat, Robert, Cohen, Claire, Prieur, Isabelle, Ramay, Tauzin, Manon, Marchand-Martin, Laetitia, Lebeaux, Cécile, Breinig, Sophie, Claris, Olivier, Tourneux, Pierre, Alexandre, Cénéric, Levy, Corinne, Jung, Camille, Dechartres, Agnès, and Durrmeyer, Xavier

Published
2021
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121. A third of premature neonates displayed inadequate 25‐hydroxyvitamin D levels before being discharged from a French neonatal intensive care unit.

Author

Laborie, Sophie, Denis, Angélique, Raverot, Véronique, Claris, Olivier, Bacchetta, Justine, and Butin, Marine

Subjects
NEONATAL intensive care units, NEWBORN infants, CHOLECALCIFEROL, INFANT nutrition, BABY foods
Abstract

Abbreviations 25(OH)D 25-hydroxyvitamin D Preterm infants risk vitamin D deficiency at birth. The correlation between 25(OH)D concentrations and birth weight, term, parathyroid hormone, urinary calcium and the urinary calcium/creatinine ratio were assessed with bivariate Spearman analyses. A third of premature neonates displayed inadequate 25-hydroxyvitamin D levels before being discharged from a French neonatal intensive care unit. [Extracted from the article]

Published
2022
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122. Preterm white matter injury: ultrasound diagnosis and classification.

Author

Agut, Thais, Alarcon, Ana, Cabañas, Fernando, Bartocci, Marco, Martinez-Biarge, Miriam, Horsch, Sandra, eurUS.brain group, Arena, Roberta, Bravo, Mayka, Carreras, Nuria, Claris, Olivier, Dudink, Jeroen, Fumagalli, Monica, Govaert, Paul, Parodi, Alessandro, Pellicer, Adelina, Ramenghi, Luca, Roehr, Charles C., Steggerda, Sylke, and Valverde, Eva

Published
2020
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124. Ultrasound of acquired posterior fossa abnormalities in the newborn.

Author

Fumagalli, Monica, Parodi, Alessandro, Ramenghi, Luca, Limperopoulos, Catherine, Steggerda, Sylke, eurUS.brain group, Agut, Thais, Alarcon, Ana, Arena, Roberta, Bartocci, Marco, Bravo, Mayka, Cabañas, Fernando, Carreras, Nuria, Claris, Olivier, Dudink, Govaert, Paul, Horsch, Sandra, Pellicer, Adelina, Roehr, Charles C., and Valverde, Eva

Published
2020
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125. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review.

Author

Camfferman, Fleur A., de Goederen, Robbin, Govaert, Paul, Dudink, Jeroen, van Bel, Frank, Pellicer, Adelina, Cools, Filip, eurUS.brain group, Agut, Thais, Alarcon, Ana, Arena, Roberta, Bartocci, Marco, Bravo, Mayka, Cabañas, Fernando, Carreras, Nuria, Claris, Olivier, Fumagalli, Monica, Horsch, Sandra, Parodi, Alessandro, and Ramenghi, Luca

Published
2020
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126. State-of-the-art neonatal cerebral ultrasound: technique and reporting.

Author

Dudink, Jeroen, Jeanne Steggerda, Sylke, Horsch, Sandra, eurUS.brain group, Agut, Thais, Alarcon, Ana, Arena, Roberta, Bartocci, Marco, Bravo, Mayka, Cabañas, Fernando, Carreras, Nuria, Claris, Olivier, Fumagalli, Monica, Govaert, Paul, Parodi, Alessandro, Pellicer, Adelina, Ramenghi, Luca, Roehr, Charles C., Steggerda, Sylke, and Valverde, Eva

Published
2020
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128. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Author

Plomgaard, Anne M., primary, Alderliesten, Thomas, additional, van Bel, Frank, additional, Benders, Manon, additional, Claris, Olivier, additional, Cordeiro, Malaika, additional, Dempsey, Eugene, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, and Greisen, Gorm, additional

Published
2018
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129. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Published
2017

130. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Published
2017

131. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

Plomgaard, Anne M., Alderliesten, Thomas, Austin, Topun, Van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H., Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Plomgaard, Anne M., Alderliesten, Thomas, Austin, Topun, Van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Van Oeveren, Wim, Pellicer, Adelina, Petersen, Tue H., Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Abstract

Background The randomized clinical trial, SafeBoosC II, examined the effect of monitoring of cerebral oxygenation by near-infrared spectroscopy combined with a guideline on treatment when cerebral oxygenation was out of the target range. Data on cerebral oxygenation was collected in both the intervention and the control group. The primary outcome was the reduction in the burden of cerebral hypo- and hyperoxia between the two groups. In this study we describe the associations between the burden of cerebral hypo- and hyperoxia, regardless of allocation to intervention or control group, and the biomarkers of brain injury from birth till term equivalent age that was collected as secondary and explorative outcomes in the SafeBoosC II trial. Methods Cerebral oxygenation was continuously monitored during the first 72h of life in 166 extremely preterm infants. Cranial ultrasound was performed at day 1,4,7,14, and 35 and at term. Electroencephalogram (EEG) was recorded at 64h. Blood-samples taken at 6 and 64 hours were analysed for the brain injury biomarkers; S100beta, brain-fatty-acid-binding-protein, and neuroketal. All analyses were conducted post hoc. Results Significantly more infants with a cerebral burden of hypoxia within the 4th quartile versus infants within quartile 1-3 were diagnosed with severe intracranial haemorrhage (11/39 versus 11/117, p = 0.003), had low burst rate on EEG (12/28 versus 21/103, p = 0.015), or died (14/41 versus 18/123, p = 0.006), whereas none of these events were significantly associated with cerebral hyperoxia. The blood biomarkers were not significantly associated with the burden of cerebral hypo- or hyperoxia. Conclusions The explorative analysis showed that early burden of cerebral hypoxia, but not hyperoxia was significantly associated with low brain electrical activity and severe intracranial haemorrhage while none of the three blood biomarkers were associated with the burden of either cerebral hypo- or hyperoxia.

Published
2017

132. Liste des collaborateurs

Author

Bacchetta, Justine, Boyer, Olivia, Adonis-Koffy, Laurence Ya, Allain-Launay, Emma, Allard, Lise, Audard, Vincent, Baudin, Florent, Baudouin, Véronique, Beauvais, Anne, Belot, Alexandre, Bensman, Albert, Bérard, Étienne, Berteloot, Laureline, Berthaud, Romain, Bertholet-Thomas, Aurélia, Bertocchio, Jean-Philippe, Biebuyck, Nathalie, Bonnefoy, Catherine, Botto, Nathalie, Boubred, Farid, Bowman, Lucie, Broux, Françoise, Cailliez, Mathilde, Cambier, Alexandra, Capito, Carmen, Charbit, Marina, Chardot, Christophe, Claris, Olivier, Clavé, Stéphanie, Cochat, Pierre, Collard, Laure, Coste, Marie-Édith, Dalodier, Emmeline, Demède, Delphine, Deschênes, Georges, Dijoud, Frédérique, Dossier, Claire, Dubourg, Laurence, Exantus, Judith, Fargue, Sonia, Fila, Marc, Frémeaux-Bacchi, Véronique, Garaix, Florentine, Garnier, Charlotte, Gillet, Yves, Gonçalves, David, Gubler, Marie-Claire, Guigonis, Vincent, Harambat, Jérôme, Hazan, Myriam, Heidet, Laurence, Hogan, Julien, Hureaux, Marguerite, Iacobelli, Sylvia, Jamin, Agnès, Jouret, François, Keller-Petrot, Isabelle, Kohaut, Jules, Krid, Saoussen, Krug-Tricot, Pauline, Kwon, Theresa, de Labriolle-Vaylet, Claire, Lachaux, Alain, Launay, Élise, Lemoine, Sandrine, Linglart, Agnès, Manucci-Lahoche, Annie, Massardier, Jérôme, Mekahli, Djalila, Morin, Denis, Nathanson, Sylvie, Naud, Corentin, Nobili, François, Novo, Robert, de Parscau, Loïc, Parvex, Paloma, Perrin, Justine, Picard, Cécile, Piètrement, Christine, Putoux, Audrey, Rabant, Marion, Ranchin, Bruno, Robert, Thomas, Rousset-Rouvière, Caroline, Roussey, Gwenaelle, Ryckewaert, Amélie, Salomon, Rémi, Sellier-Leclerc, Anne-Laure, Sérusclat, André, Tanné, Corentin, Thaunat, Olivier, Tsimaratos, Michel, Ulinski, Tim, Vargas-Poussou, Rosa, Vrillon, Isabelle, Zaloszyc, Ariane, and Zennaro, Maria Christina

Published
2020
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133. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation

Author

Durrmeyer, Xavier, Breinig, Sophie, Claris, Olivier, Tourneux, Pierre, Alexandre, Ceneric, Saliba, Elie, Beuchee, Alain, Jung, Camille, Levy, Corinne, Marchand-Martin, Laetitia, Marcoux, Marie-Odile, Dechartres, Agnes, Danan, Claude, Grp, Prettineo Res, Centre Hospitalier Intercommunal de Créteil (CHIC), CHU Toulouse [Toulouse], Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL), Périnatalité et Risques Toxiques - UMR INERIS_I 1 (PERITOX), Institut National de l'Environnement Industriel et des Risques (INERIS)-Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Ressource Biologique [CHI Créteil] (Centre de Recherche Clinique), Association Clinique et Thérapeutique Infantile du Val de Marne (ACTIV), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Unité de soins intensifs néonatals [Hôpital des Enfants, Toulouse], CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de réanimation néonatale, CHI Créteil, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Réanimation néonatale et pédiatrique spécialisée [CHU Toulouse], Pôle Enfants [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Atropine, Sufentanil, [SDV]Life Sciences [q-bio], Sedation, Birth weight, medicine.medical_treatment, Blood Pressure, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, Heart Rate, law, Intensive Care Units, Neonatal, 030225 pediatrics, Intubation, Intratracheal, medicine, Humans, Intubation, 030212 general & internal medicine, Propofol, Original Investigation, Analgesics, business.industry, Infant, Newborn, Gestational age, General Medicine, Oxygen, Anesthesia, Atracurium, Drug Therapy, Combination, Premedication, medicine.symptom, business, Adjuvants, Anesthesia, medicine.drug
Abstract

IMPORTANCE: Propofol or a combination of a synthetic opioid and muscle relaxant are both recommended for premedication before neonatal intubation but have yet to be compared. OBJECTIVE: To compare prolonged desaturation during neonatal nasotracheal intubation after premedication with atropine-propofol vs atropine-atracurium-sufentanil treatment. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, randomized clinical trial (2012-2016) in 6 NICUs in France that included 173 neonates requiring nonemergency intubation. The study was interrupted due to expired study kits and lack of funding. INTERVENTIONS: Eighty-nine participants were randomly assigned to the atropine-propofol group and 82 to the atropine-atracurium-sufentanil group before nasotracheal intubation. MAIN OUTCOMES AND MEASURES: The primary outcome was prolonged desaturation (Spo(2 60 seconds), using intention-to-treat analysis using mixed models. Secondary outcomes assessed the characteristics of the procedure and its tolerance. RESULTS: Of 173 neonates randomized (mean gestational age, 30.6 weeks; mean birth weight, 1502 g; 71 girls), 171 (99%) completed the trial. Of 89 infants, 53 (59.6%) in the atropine-propofol group vs 54 of 82 (65.9%) in the atropine-atracurium-sufentanil group achieved the primary outcome (adjusted RD, −6.4; 95% CI, −21.0 to 8.1; P = .38). The atropine-propofol group had a longer mean procedure duration than did the atropine-atracurium-sufentanil group (adjusted RD, 1.7 minutes; 95% CI, 0.1-3.3 minutes; P = .04); a less frequent excellent quality of sedation rate, 51.7% (45 of 87) vs 92.6% (75 of 81; P

Published
2018
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134. Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study

Author

Fischer Fumeaux, Céline J., primary, Denis, Angélique, additional, Prudon, Malika B., additional, Plaisant, Frank, additional, Essomo Megnier-Mbo, Christine Murielle, additional, Fernandes, Laetitia, additional, Touzet, Sandrine, additional, Claris, Olivier, additional, and Laborie, Sophie, additional

Published
2017
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135. Leading causes of preterm delivery as risk factors for intraventricular hemorrhage in very preterm infants: results of the EPIPAGE 2 cohort study

Author

Chevallier, Marie, primary, Debillon, Thierry, additional, Pierrat, Veronique, additional, Delorme, Pierre, additional, Kayem, Gilles, additional, Durox, Mélanie, additional, Goffinet, François, additional, Marret, Stephane, additional, Ancel, Pierre Yves, additional, Arnaud, Catherine, additional, Baud, Olivier, additional, Bednarek, Nathalie, additional, Claris, Olivier, additional, Flamant, Cyril, additional, Gire, Catherine, additional, Saliba, Elie, additional, Brissaud, Olivier, additional, Charkaluk, Marie Laure, additional, Favrais, Geraldine, additional, and Bodeau-Livinec, Florence, additional

Published
2017
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136. Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial

Author

Plomgaard, Anne M., primary, Alderliesten, Thomas, additional, Austin, Topun, additional, van Bel, Frank, additional, Benders, Manon, additional, Claris, Olivier, additional, Dempsey, Eugene, additional, Fumagalli, Monica, additional, Gluud, Christian, additional, Hagmann, Cornelia, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, van Oeveren, Wim, additional, Pellicer, Adelina, additional, Petersen, Tue H., additional, Pichler, Gerhard, additional, Winkel, Per, additional, and Greisen, Gorm, additional

Published
2017
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138. Survival and Morbidity of Preterm Children Born at 22 Through 34 Weeks’ Gestation in France in 2011

Author

Ancel, Pierre-Yves, Goffinet, François, Kuhn, Pierre, Langer, Bruno, Matis, Jacqueline, Hernandorena, Xavier, Chabanier, Pierre, Joly-Pedespan, Laurence, Lecomte, Bénédicte, Vendittelli, Françoise, Dreyfus, Michel, Guillois, Bernard, Burguet, Antoine, Sagot, Pierre, Sizun, Jacques, Beuchée, Alain, Rouget, Florence, Favreau, Amélie, Saliba, Elie, Bednarek, Nathalie, Morville, Patrice, Thiriez, Gérard, Marpeau, Loïc, Marret, Stéphane, Kayem, Gilles, Durrmeyer, Xavier, Granier, Michèle, Baud, Olivier, Jarreau, Pierre-Henri, Mitanchez, Delphine, Boileau, Pascal, Boulot, Pierre, Cambonie, Gilles, Daudé, Hubert, Bédu, Antoine, Mons, Fabienne, Fresson, Jeanne, Vieux, Rachel, Alberge, Catherine, Arnaud, Catherine, Vayssiere, Christophe, Truffert, Patrick, Pierrat, Véronique, Subtil, Damien, d’Ercole, Claude, Gire, Catherine, Siméoni, Umberto, Bongain, André, Sentilhes, Loïc, Roze, Jean-Christophe, Gondry, Jean, Leke, André, Deiber, Michel, Claris, Olivier, Picaud, Jean-Charles, Ego, Anne, Debillon, Thierry, Poulichet, Anne, Coliné, Eliane, Favre, Anne, Fléchelles, Olivier, Samperiz, Sylvain, Ramful, Duksha, Branger, Bernard, Benhammou, Valérie, Foix-L’Hélias, Laurence, Marchand-Martin, Laetitia, Kaminski, Monique, Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants (UMR_S 953), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Descartes - Paris 5 (UPD5)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris-Sud - Paris 11 (UP11), Service de gynécologie–obstétrique, CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Centre de compétences des microangiopathies thrombotiques, CHU Bordeaux [Bordeaux], Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Service de Gynécologie-Obstétrique et Médecine de la Reproduction [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Gynécologie Obstétrique, Médecine Foetale et Stérilité Conjugale - Chirurgie Gynécologie et Oncologique [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Département de Pédiatrie, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre de Recherche en Sciences et Technologies de l'Information et de la Communication - EA 3804 (CRESTIC), Université de Reims Champagne-Ardenne (URCA), Service de cardiologie pédiatrique, Centre Hospitalier Universitaire de Reims (CHU Reims), Service Pédiatrie, Hôpital Saint-Jacques-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Team 4 'NeoVasc' - INSERM U1245, Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie-Obstétrique [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Médecine néonatale, Centre Hospitalier Sud Francilien, CH Evry-Corbeil-CH Evry-Corbeil, Physiopathologie, conséquences fonctionnelles et neuroprotection des atteintes du cerveau en développement, Université Paris Diderot - Paris 7 (UPD7)-IFR2-Institut National de la Santé et de la Recherche Médicale (INSERM), PremUp Foundation, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Descartes - Paris 5 (UPD5)-CHI Créteil-Institut de Recherche pour le Développement (IRD)-Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Diderot - Paris 7 (UPD7), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Néonatalogie, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Aix Marseille Université (AMU), Service de Pédiatrie médicale - réanimation et néonatologie [CHU Limoges], CHU Limoges, Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé, CCTIRS, Unité de Néonatalogie, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), INSERM, U1027, Toulouse, France., Service de gynécologie obstétrique, CHU Toulouse [Toulouse]-Hôpital Paule de Viguier, CHU Toulouse [Toulouse], Unité de Recherche Clinique, Hôpital Jeanne de Flandre [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Département de Pédiatrie-Néonatologie, Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Vascular research center of Marseille (VRCM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Service de Gynécologie-Obstétrique-Reproduction, Hôpital l'Archet, Service de gynécologie-obstétrique, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Département de Périnatologie, Hôpital Mère Enfant, Transporteurs membranaires, chimioresistance et drug-design (TMCD2), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Santé Individu Société - SIS (SIS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université Lumière - Lyon 2 (UL2), Service de Néonatalogie [Lyon], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Registre des Handicaps de l'Enfant et Observatoire Périnatal Isère, RHEOP, Réseau Périnat de Guyane [Cayenne, Guyanne Française], Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Réseau Sécurité Naissance - Naître Ensemble, Nantes, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de pédiatrie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Team 4 NeoVasc - Region Team ERI 28 INSERM (Neovasc), Institut de Recherche pour le Développement (IRD)-Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Diderot - Paris 7 (UPD7)-CHI Créteil-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Gynécologie [CHU Toulouse], Pôle Femme-Mère-Couple [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Santé Individu Société (SIS), Université Lumière - Lyon 2 (UL2)-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pascal - Clermont Auvergne (IP), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Service Pédiatrique, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université de Franche-Comté (UFC), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hopital Louis Mourier - AP-HP [Colombes], Institut de Recherche pour le Développement (IRD)-Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Diderot - Paris 7 (UPD7)-CHI Créteil-Université Paris Descartes - Paris 5 (UPD5)-Sorbonne Universités-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Centre Hospitalier de Poissy Saint-Germain (CHIPS), Service de Néonatalogie [Croix-Rousse - Lyon], Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), SIGMA Clermont (SIGMA Clermont)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université d'Angers (UA), and Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
[SDV]Life Sciences [q-bio], cohort, neonatal morbidity, ComputingMilieux_MISCELLANEOUS
Abstract

International audience; Importance Up-to-date estimates of the health outcomes of preterm children are needed for assessing perinatal care, informing parents, making decisions about care, and providing evidence for clinical guidelines. Objectives To determine survival and neonatal morbidity of infants born from 22 through 34 completed weeks’ gestation in France in 2011 and compare these outcomes with a comparable cohort in 1997. Design, Setting, and Participants The EPIPAGE-2 study is a national, prospective, population-based cohort study conducted in all maternity and neonatal units in France in 2011. A total of 2205 births (stillbirths and live births) and terminations of pregnancy at 22 through 26 weeks’ gestation, 3257 at 27 through 31 weeks, and 1234 at 32 through 34 weeks were studied. Cohort data were collected from January 1 through December 31, 1997, and from March 28 through December 31, 2011. Analyses for 1997 were run for the entire year and then separately for April to December; the rates for survival and morbidities did not differ. Data are therefore presented for the whole year in 1997 and the 8-month and 6-month periods in 2011. Main Outcomes and Measures Survival to discharge and survival without any of the following adverse outcomes: grade III or IV intraventricular hemorrhage, cystic periventricular leukomalacia, severe bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher), or necrotizing enterocolitis (stages 2-3). Results A total of 0.7% of infants born before 24 weeks’ gestation survived to discharge: 31.2% of those born at 24 weeks, 59.1% at 25 weeks, and 75.3% at 26 weeks. Survival rates were 93.6% at 27 through 31 weeks and 98.9% at 32 through 34 weeks. Infants discharged home without severe neonatal morbidity represented 0% at 23 weeks, 11.6% at 24 weeks, 30.0% at 25 weeks, 47.5% at 26 weeks, 81.3% at 27 through 31 weeks, and 96.8% at 32 through 34 weeks. Compared with 1997, the proportion of infants surviving without severe morbidity in 2011 increased by 14.4% (P

Published
2015
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139. PROSPERO : Programme de Recherche sur l’Optimisation du Suivi des Patientes à Risque en Obstétrique

Author

Gaucher, Laurent, Rudigoz, Renè-Charles, Gaucherand, Pascal, Doret, Muriel, Dubernard, Gil, Flori, Marie, Goffinet, François, Claris, Olivier, Colin, Cyrille, Dupont, Corinne, Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), Service d'Anesthésie et de Soins Intensifs [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Réseau périnatal Aurore, Santé Individu Société (SIS), Université Lumière - Lyon 2 (UL2)-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Health Service and Performance Research (HESPER), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Laboratoire de Physique de l'ENS Lyon (Phys-ENS), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche Saint-Antoine (UMRS893), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon, Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants (UMR_S 953), Université Paris-Sud - Paris 11 (UP11)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Gynécologie et Obstétrique [Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Collège National des Gynécologues et Obstétriciens Français (CNGOF), Service Réanimation Néonatale, Groupement Hospitalier Est, Hospices Civils de Lyon, Hospices Civils de Lyon (HCL)-Groupement Hospitalier Est, Pôle Information Médicale Evaluation Recherche (IMER), Collège National des Sages-Femmes de France, Hôpital Femme Mère Enfant [CHU - HCL] ( HFME ), Hospices Civils de Lyon ( HCL ), Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Hôpital de la Croix-Rousse [CHU - HCL], Santé Individu Société - SIS ( SIS ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Jean Monnet [Saint-Étienne] ( UJM ) -Hospices Civils de Lyon ( HCL ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon III ( UJML ) -Université Lumière - Lyon 2 ( UL2 ), Health Service and Performance Research ( HESPER ), Laboratoire de Physique de l'ENS Lyon ( Phys-ENS ), École normale supérieure - Lyon ( ENS Lyon ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique ( CNRS ), Centre de Recherche Saint-Antoine ( UMRS893 ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Recherche Epidémiologique en Santé Périnatale et Santé des Femmes et des Enfants ( UMR_S 953 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris-Sud - Paris 11 ( UP11 ), Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Cochin [AP-HP], Collège National des Gynécologues et Obstétriciens Français ( CNGOF ), Hospices Civils de Lyon ( HCL ) -Groupement Hospitalier Est, Pôle Information Médicale Evaluation Recherche ( IMER ), Santé Individu Société - SIS (SIS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université Lumière - Lyon 2 (UL2), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Descartes - Paris 5 (UPD5)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Université Paris-Sud - Paris 11 (UP11), and Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
trajectoire, système d'information médical, dossier médical partagé, obstétrique, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, [ SDV.MHEP.GEO ] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, parcours de soin
Abstract

National audience; Essai multicentrique contrôlé randomisé ouvert. Randomisation des patientes lors de l’inscription dans l’une de deux des maternités des Hospices Civils de Lyon.Groupe Témoin : suivi des patientes selon les modalités habituelles.Groupe Intervention : suivi des patientes avec :1. Accès au SIVPH par les soignants de ville (via le serveur MyHCL pro) et de l’hôpital (via le logiciel Easily) ainsi que par les patientes (via le serveur MyHCL) pour faciliter la transmission de données médicales ;En début de grossesse :2. Recueil des facteurs de risque des patientes,3. Proposition d’un parcours adapté à leurs facteurs de risque,Pendant la grossesse :4. Propositions automatiques de prescriptions pour les soignants,5. Propositions automatiques de modification du parcours des patientes pour les soignants,6. Saisie des résultats des examens réalisés en ville par les patientes,7. Rappels automatiques (envoi de SMS) aux patientes des rendez-vous et des examens à réaliser,8. Surveillance du parcours des femmes via un tableau de bord par une sage-femme coordinatrice,En salle de naissance :9. Synthèse des facteurs de risque à l’entrée en salle d’accouchement,10. Rappels dynamiques des facteurs de risque survenant pendant le travail.

Published
2015

140. No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life.

Author

Plomgaard, Anne M., Alderliesten, Thomas, van Bel, Frank, Benders, Manon, Claris, Olivier, Cordeiro, Malaika, Dempsey, Eugene, Fumagalli, Monica, Gluud, Christian, Hyttel‐Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Greisen, Gorm, and Hyttel-Sorensen, Simon

Subjects
OXIMETRY, CEREBRAL anoxia, CEREBROVASCULAR disease, OXYGEN in the body, PREMATURE infants
Abstract

Aim: Cerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age.Methods: In 2012-2013, the phase II randomised Safeguarding the Brains of our smallest Children trial compared visible cerebral near-infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group. Cerebral hypoxia was significantly reduced in the intervention group. We followed up 115 survivors from eight European centres at two years of corrected age, by conducting a medical examination and assessing their neurodevelopment with the Bayley Scales of Infant and Toddler Development, Second or Third Edition, and the parental Ages and Stages Questionnaire (ASQ).Results: There were no differences between the intervention (n = 65) and control (n = 50) groups with regard to the mean mental developmental index (89.6 ± 19.5 versus 88.4 ± 14.7, p = 0.77), ASQ score (215 ± 58 versus 213 ± 58, p = 0.88) and the number of children with moderate-to-severe neurodevelopmental impairment (10 versus six, p = 0.58).Conclusion: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age. [ABSTRACT FROM AUTHOR]

Published
2019
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141. The SafeBoosC II randomized trial:treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue Hvass, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue Hvass, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Abstract

BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95)) and blood biomarkers of brain injury (S100β, brain fatty acid-binding protein, and neuroketal).METHODS: One hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age.RESULTS: One hundred and thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 vs. control 7.7 burst/min) or SEF95 (experimental 18.1 vs. control 18.0 Hz). The two groups did not differ regarding blood S100β, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants).CONCLUSION: Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.

Published
2016

142. Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial : cranial ultrasound and magnetic resonance imaging assessments

Author

Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Benders, Manon, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Benders, Manon

Published
2016

143. The SafeBoosC II randomized trial : treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue H, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue H, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Published
2016

144. Brain injury in the international multicentre randomised SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

Author

MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Benders, Manon, MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Benders, Manon

Published
2016

145. The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings

Author

MS Neonatologie, Regenerative Medicine and Stem Cells, Riera, Joan, Hyttel-Sorensen, Simon, Bravo, María Carmen, Cabañas, Fernando, López-Ortego, Paloma, Sanchez, Laura, Ybarra, Marta, Dempsey, Eugene, Greisen, Gorm, Austin, Topun, Claris, Olivier, Fumagalli, Monica, Gluud, Christian, Lemmers, Petra, Pichler, Gerhard, Plomgaard, Anne Mette, van Bel, Frank, Wolf, Martin, Pellicer, Adelina, MS Neonatologie, Regenerative Medicine and Stem Cells, Riera, Joan, Hyttel-Sorensen, Simon, Bravo, María Carmen, Cabañas, Fernando, López-Ortego, Paloma, Sanchez, Laura, Ybarra, Marta, Dempsey, Eugene, Greisen, Gorm, Austin, Topun, Claris, Olivier, Fumagalli, Monica, Gluud, Christian, Lemmers, Petra, Pichler, Gerhard, Plomgaard, Anne Mette, van Bel, Frank, Wolf, Martin, and Pellicer, Adelina

Published
2016

146. The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Author

MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue H, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, Greisen, Gorm, MS Neonatologie, Brain, Regenerative Medicine and Stem Cells, Plomgaard, Anne M, van Oeveren, Wim, Petersen, Tue H, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Benders, Manon, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Hagmann, Cornelia, Hyttel-Sorensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Winkel, Per, and Greisen, Gorm

Published
2016

147. The SafeBoosC phase II clinical trial:an analysis of the interventions related with the oximeter readings

Author

Riera, Joan, Hyttel-Sorensen, Simon, Bravo, María Carmen, Cabañas, Fernando, López-Ortego, Paloma, Sanchez, Laura, Ybarra, Marta, Dempsey, Eugene, Greisen, Gorm, Austin, Topun, Claris, Olivier, Fumagalli, Monica, Gluud, Christian, Lemmers, Petra, Pichler, Gerhard, Plomgaard, Anne Mette, van Bel, Frank, Wolf, Martin, Pellicer, Adelina, Riera, Joan, Hyttel-Sorensen, Simon, Bravo, María Carmen, Cabañas, Fernando, López-Ortego, Paloma, Sanchez, Laura, Ybarra, Marta, Dempsey, Eugene, Greisen, Gorm, Austin, Topun, Claris, Olivier, Fumagalli, Monica, Gluud, Christian, Lemmers, Petra, Pichler, Gerhard, Plomgaard, Anne Mette, van Bel, Frank, Wolf, Martin, and Pellicer, Adelina

Abstract

BACKGROUND: The SafeBoosC phase II randomised clinical trial recently demonstrated the benefits of a combination of cerebral regional tissue oxygen saturation (rStO2) by near-infrared spectroscopy (NIRS) and a treatment guideline to reduce the oxygen imbalance in extremely preterm infants.AIMS: To analyse rStO2-alarm-related clinical decisions and their heterogeneity in the NIRS experimental group (NIRS monitoring visible) and their impact on rStO2 and SpO2.METHODS: Continuous data from NIRS devices and the alarms (area under the curve of the rStO2 out of range had accumulated 0.2%h during 10 min), clinical data at discrete time points and interventions prompted by the alarms were recorded.RESULTS: Sixty-seven infants had data that fulfilled the requirements for this analysis. 1107 alarm episodes were analysed. The alarm triggered a treatment guideline intervention in 25% of the cases; the type of intervention chosen varied among clinical sites. More than 55% of alarms were not followed by an intervention ('No action'); additionally, in 5% of alarms the rStO2 value apparently was considered non-reliable and the sensor was repositioned. The percentage of unresolved alarms at 30 min after 'No action' almost doubled the treatment guideline intervention (p<0.001). Changes in peripheral oxygen saturation (SpO2), were observed only after treatment guideline interventions.CONCLUSIONS: This study shows that 25% of rStO2 alarms were followed by a clinical intervention determined by the treatment guideline. However, the rStO2 and SpO2 returned to normal ranges after the intervention, supporting the notion that decisions taken by the clinicians were appropriate.TRIAL REGISTRATION NUMBER: ClinicalTrial.gov NCT01590316.

Published
2016

148. Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial:cranial ultrasound and magnetic resonance imaging assessments

Author

Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, Benders, Manon, Plomgaard, Anne M, Hagmann, Cornelia, Alderliesten, Thomas, Austin, Topun, van Bel, Frank, Claris, Olivier, Dempsey, Eugene, Franz, Axel, Fumagalli, Monica, Gluud, Christian, Greisen, Gorm, Hyttel-Sørensen, Simon, Lemmers, Petra, Pellicer, Adelina, Pichler, Gerhard, and Benders, Manon

Abstract

BACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular hemorrhages and lower developmental score. In SafeBoosC II, we obtained a significant reduction of cerebral hypoxia by monitoring cerebral oxygenation in combination with a treatment guideline. Here, we describe (i) difference in brain injury between groups, (ii) feasibility of serial cranial ultrasound (cUS) and magnetic resonance imaging (MRI), (iii) local and central cUS assessment.METHODS: Hundred and sixty-six extremely preterm infants were included. cUS was scheduled for day 1, 4, 7, 14, and 35 and at term-equivalent age (TEA). cUS was assessed locally (unblinded) and centrally (blinded). MRI at TEA was assessed centrally (blinded). Brain injury classification: no, mild/moderate, or severe.RESULTS: Severe brain injury did not differ significantly between groups: cUS (experimental 10/80, control 18/77, P = 0.32) and MRI (5/46 vs. 3/38, P = 0.72). Kappa values for local and central readers were moderate-to-good for severe and poor-to-moderate for mild/moderate injuries. At TEA, cUS and MRI were assessed in 72 and 64%, respectively.CONCLUSION: There was no difference in severe brain injury between groups. Acquiring cUS and MRI according the standard operating procedures must be improved for future trials. Whether monitoring cerebral oxygenation during the first 72 h of life prevents brain injury should be evaluated in larger multicenter trials.

Published
2016

149. Wide geographical dissemination of the multiresistant Staphylococcus capitis NRCS-A clone in neonatal intensive-care units

Author

Butin, Marine, Ibrahimi, Abdelhafid, Claris, Olivier, Vandenesch, F., Picaud, Jean Charles, Laurent, Frederic, Rasigade, Jean Philippe, Martins-Simões, Patrícia, Meugnier, Hélène, Lemriss, Hajar, Goering, Richard, Kearns, Angela, Deighton, M., Denis, Olivier, Butin, Marine, Ibrahimi, Abdelhafid, Claris, Olivier, Vandenesch, F., Picaud, Jean Charles, Laurent, Frederic, Rasigade, Jean Philippe, Martins-Simões, Patrícia, Meugnier, Hélène, Lemriss, Hajar, Goering, Richard, Kearns, Angela, Deighton, M., and Denis, Olivier

Abstract

Nosocomial late-onset sepsis represents a frequent cause of morbidity and mortality in preterm neonates. The Staphylococcus capitis clone NRCS-A has been previously described as an emerging cause of nosocomial bacteraemia in French neonatal intensive-care units (NICUs). In this study, we aimed to explore the possible unrecognized dissemination of this clone on a larger geographical scale. One hundred methicillin-resistant S. capitis strains isolated from neonates (n = 86) and adult patients (n = 14) between 2000 and 2013 in four different countries (France, Belgium, the UK, and Australia) were analysed with SmaI pulsed-field gel electrophoresis (PFGE) and dru typing. The vast majority of NICU strains showed the NRCS-A pulsotype and the dt11c type (96%). We then randomly selected 14 isolates (from neonates, n = 12, three per country; from adult patients, n = 2), considered to be a subset of representative isolates, and performed further molecular typing (SacII PFGE, SCCmec typing, and multilocus sequence typing-like analysis), confirming the clonality of the S. capitis strains isolated from neonates, despite their distant geographical origin. Whole genome single-nucleotide polymorphism-based phylogenetic analysis of five NICU isolates (from the different countries) attested to high genetic relatedness within the NRCS-A clone. Finally, all of the NRCS-A strains showed multidrug resistance (e.g. methicillin and aminoglycoside resistance, and decreased vancomycin susceptibility), with potential therapeutic implications for infected neonates. In conclusion, this study represents the first report of clonal dissemination of methicillin-resistant coagulase-negative Staphylococcus clone on a large geographical scale. Questions remain regarding the origin and means of international spread, and the reasons for this clone's apparent predilection for neonates., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2016

150. Management and outcome challenges in newborns with gastroschisis: A 6-year retrospective French study

Author

Tosello, Barthelemy, primary, Zahed, Meriem, additional, Guimond, Floriane, additional, Baumstarck, Karine, additional, Faure, Alice, additional, Michel, Fabrice, additional, Claris, Olivier, additional, Gire, Catherine, additional, Berakdar, Isabelle, additional, Massardier, Jerome, additional, D’Ercole, Claude, additional, and Merrot, Thierry, additional

Published
2016
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