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52. Identifying the target population for primary Respiratory Syncytial Virus two-step prevention in infants: Normative Outcome of Hospitalisation Assessment for Newborns (NOHAN)

Author

Jourdain, Marine, primary, Benchaib, Mehdi, additional, Ploin, Dominique, additional, Gillet, Yves, additional, Javouhey, Etienne, additional, Horvat, Côme, additional, Massoud, Mona, additional, Butin, Marine, additional, Claris, Olivier, additional, Lina, Bruno, additional, and Casalegno, Jean-Sebastien, additional

Published
2022
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53. Early cerebral hypoxia in extremely preterm infants and neurodevelopmental impairment at 2 year of age: A post hoc analysis of the SafeBoosC II trial

Author

Plomgaard, Anne Mette, primary, Schwarz, Christoph E., additional, Claris, Olivier, additional, Dempsey, Eugene M., additional, Fumagalli, Monica, additional, Hyttel-Sorensen, Simon, additional, Lemmers, Petra, additional, Pellicer, Adelina, additional, Pichler, Gerhard, additional, and Greisen, Gorm, additional

Published
2022
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54. Leading causes of preterm delivery as risk factors for intraventricular hemorrhage in very preterm infants: results of the EPIPAGE 2 cohort study

Author

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

Published
2017
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55. 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, and Pellicer, Adelina

Published
2016
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57. Low levels of respiratory syncytial virus activity in Europe during the 2020/21 season: what can we expect in the coming summer and autumn/winter?

Author

van Summeren, Jojanneke, Meijer, Adam, Aspelund, Guðrún, Casalegno, Jean Sebastien, Erna, Guðrún, Hoang, Uy, Lina, Bruno, de Lusignan, Simon, Teirlinck, Anne C., Thors, Valtýr, Paget, John, Ouziel, Antoine, Tardy, Jean-claude, Gaucherand, Pascal, Massardier, Jerome, Polazzi, Stephanie, Duclos, Antoine, Benchaib, Mehdi, Cartier, Regine, Jourdain, Marine, Ottmann, Michelle, Kramer, Rolf, Fiorini, Sylvie, Rivat, Nathalie, Mekki, Yahia, Fort-Jacquier, Julie, Barral, Maud-Catherine, Noelie, Vey, Haesebaert, Julie, Horvat, Come, Vidoni, Leo, Reynes, Jean-Marc, Eleouet, Jean-Francois, Josset, Laurence, Receveur, Matthieu, Javouhey, Etienne, Ploin, Dominique, Valette, Martine, Fanget, Remi, Targe, Sandrine Couray, Myar-Dury, Anne-Florence, Doret-Dion, Muriel, Massoud, Mona, Masson, Elsa, Bard, Emilie, Queromes, Gregory, Vanhems, Phillipe, Claris, Olivier, Butin, Marine, Ader, Florence, Bin, Sylvie, Gaymard, Alexandre, Morfin, Florence, Gillet, Yves, Netherlands Institute for Health Services Research [Utrecht] (NIVEL), National Institute for Public Health and the Environment [Bilthoven] (RIVM), Directorate of Health [Reykjavík], Institut des Agents Infectieux [Lyon] (IAI), Hospices Civils de Lyon (HCL), Landspitali National University Hospital of Iceland, University of Oxford [Oxford], Children’s Hospital [Reykjavik, Iceland], University of Iceland [Reykjavik], This study is performed as a side project of the RSV ComNet study. The aim of the RSV ComNet project is to measure the disease burden of RSV in children aged ≤5 years in primary care, and is funded by Sanofi Pasteur and AstraZeneca., VRS study group in Lyon: Antoine Ouziel, Jean-claude Tardy, Pascal Gaucherand, Jerome Massardier, Stephanie Polazzi, Antoine Duclos, Mehdi Benchaib, Regine Cartier, Marine Jourdain, Michelle Ottmann, Rolf Kramer, Sylvie Fiorini, Nathalie Rivat, Yahia Mekki, Julie Fort-Jacquier, Maud-Catherine Barral, Vey Noelie, Julie Haesebaert, Come Horvat, Leo Vidoni, Jean-Marc Reynes, Jean-Francois Eleouet, Laurence Josset, Matthieu Receveur, Etienne Javouhey, Dominique Ploin, Martine Valette, Remi Fanget, Sandrine Couray Targe, Anne-Florence Myar-Dury, Muriel Doret-Dion, Mona Massoud, Elsa Masson, Emilie Bard, Gregory Queromes, Phillipe Vanhems, Olivier Claris, Marine Butin, Florence Ader, Sylvie Bin, Alexandre Gaymard, Florence Morfin, Yves Gillet, and Lyon, VRS study group in

Subjects
Author's Correction, 0301 basic medicine, Veterinary medicine, viruses, Iceland, surveillance data, MESH: Respiratory Syncytial Virus, Human, Respiratory syncytial virus, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Child, Epidemiology, MESH: COVID-19, 030212 general & internal medicine, Respiratory system, Child, virus diseases, RSV, respiratory system, MESH: Iceland, MESH: Infant, Europe, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, epidemiology, France, Seasons, Winter season, Rapid Communication, medicine.medical_specialty, 2019-20 coronavirus outbreak, Surveillance data, Coronavirus disease 2019 (COVID-19), COVID-19 pandemic, Respiratory Syncytial Virus Infections, Biology, Virus, 03 medical and health sciences, MESH: Respiratory Syncytial Virus Infections, Virology, medicine, Humans, MESH: SARS-CoV-2, MESH: Humans, SARS-CoV-2, Public Health, Environmental and Occupational Health, Small children, COVID-19, Infant, MESH: France, 030104 developmental biology, Respiratory Syncytial Virus, Human, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Europe, MESH: Seasons
Abstract

International audience; Since the introduction of non-pharmacological interventions to control COVID-19, respiratory syncytial virus (RSV) activity in Europe has been limited. Surveillance data for 17 countries showed delayed RSV epidemics in France (≥ 12 w) and Iceland (≥ 4 w) during the 2020/21 season. RSV cases (predominantly small children) in France and Iceland were older compared with previous seasons. We hypothesise that future RSV epidemic(s) could start outside the usual autumn/winter season and be larger than expected. Year-round surveillance of RSV is of critical importance.

Published
2021
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58. Fatal Neonatal DOLK-CDG as a Rare Form of Syndromic Ichthyosis

Author

Komlosi, Katalin, primary, Claris, Olivier, additional, Collardeau-Frachon, Sophie, additional, Kopp, Julia, additional, Hausser, Ingrid, additional, Mazereeuw-Hautier, Juliette, additional, Jonca, Nathalie, additional, Zimmer, Andreas D., additional, Sanlaville, Damien, additional, and Fischer, Judith, additional

Published
2021
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63. Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study

Author

Pierrat, Véronique, Marchand-Martin, Laetitia, Marret, Stéphane, Arnaud, Catherine, Benhammou, Valérie, Cambonie, Gilles, Debillon, Thierry, Dufourg, Marie-Noëlle, Gire, Catherine, Goffinet, François, Kaminski, Monique, Lapillonne, Alexandre, Morgan, Andrei Scott, Rozé, Jean-Christophe, Twilhaar, Sabrina, Charles, Marie-Aline, Ancel, Pierre-Yves, Langer, Bruno, Matis, Jacqueline, Kuhn, Pierre, Rebola, Muriel, Renesme, Laurent, Joly, Laurent, Lecomte, Benedicte, Datin-Dorriere, Valerie, Guillois, Bernard, Burguet, Antoine, Semama, Denis, Roué, Jean-Michel, Bretaudeau, Gilles, Rouget, Florence, Saliba, Elie, Favaris, Géraldine, Bednarek, Nathalie, Loron, Gauthier, Thiriez, Gerard, Chadie, Alexandra, de la Villéon, Gaëlle, Durrmeyer, Xavier, Granier, Michèle, Boileau, Pascal, Kayem, Gilles, Jarreau, Pierre-Henri, Foix-L’Hélias, Laurence, Boulot, Pierre, Daudé, Hubert, Bédu, Antoine, Mons, Fabienne, Deforge, Hélène, Fresson, Jeanne, Vayssière, Christophe, Breinig, Sophie, Truffert, Patrick, Nuytten, Alexandra, Charkaluk, Marie Laure, Brevaut, Veronique, Zahed, Meriem, Garcia, Patricia, Fayol, Laurence, Flamant, Cyril, Muller, Jean-Baptiste, Gascoin, Géraldine, Leke, André, Fontaine, Cécile, Claris, Olivier, Picaud, Jean-Charles, Ego, Anne, Patural, Hughes, Poulichet, Anne, Abrial, Aude, Favre, Anne, Fléchelles, Olivier, Ramful, Duksha, Carbonnier, Magali, Simeon, Thierry, 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)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University College of London [London] (UCL), CHU Rouen, Normandie Université (NU), MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525 (TIMC ), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA), Etude longitudinale française depuis l'enfance (UMS : Ined-Inserm-EFS) (ELFE), Institut national d'études démographiques (INED)-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance Publique - Hôpitaux de Marseille (APHM), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Paris (UP), Centre hospitalier universitaire de Nantes (CHU Nantes), CIC - Mère Enfant Necker Cochin Paris Centre (CIC 1419), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), French Institute of Public Health Research/Institute of Public HealthFrench Health MinistryPREMUP FoundationFondation de France11779Foundation for Medical ResearchSPF20160936356hospital clinical research programme EpinutriDGOS13-040Institut National de la Sante et de la Recherche Medicale (Inserm)National Institute of CancerNational Solidarity Fund for Autonomy (CNSA), ANR-11-EQPX-0038,RE-CO-NAI,Plateforme de REcherche sur les COhortes d'enfants suivis depuis la NAIssance(2011), Paris Diderot, Equipe HAL, Equipements d'excellence - Plateforme de REcherche sur les COhortes d'enfants suivis depuis la NAIssance - - RE-CO-NAI2011 - ANR-11-EQPX-0038 - EQPX - VALID, Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Université des Antilles (UA)-Etablissement français du don du sang [Montpellier], Modélisation et Évaluation des données complexes en Santé Publique (TIMC-MESP), Université Grenoble Alpes (UGA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Paris Cité (UPCité), Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)

Subjects
Male, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Research, [SDV]Life Sciences [q-bio], Age Factors, Infant, Newborn, Gestational Age, Infant, Premature, Diseases, Cohort Studies, [SDV] Life Sciences [q-bio], Child Development, Neurodevelopmental Disorders, Case-Control Studies, Child, Preschool, Humans, Female, France, Infant, Premature, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Abstract Objectives To describe neurodevelopment at age 5 among children born preterm. Design Population based cohort study, EPIPAGE-2. Setting France, 2011. Participants 4441 children aged 5½ born at 24-26, 27-31, and 32-34 weeks Main outcome measures Severe/moderate neurodevelopmental disabilities, defined as severe/moderate cerebral palsy (Gross Motor Function Classification System (GMFCS) ≥2), or unilateral or bilateral blindness or deafness, or full scale intelligence quotient less than minus two standard deviations (Wechsler Preschool and Primary Scale of Intelligence, 4th edition). Mild neurodevelopmental disabilities, defined as mild cerebral palsy (GMFCS-1), or visual disability ≥3.2/10 and

Published
2021
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64. Fetal growth restriction: underdiagnosed condition with non-optimal screening.

Author

Atallah, Anthony, Butin, Marine, Moret, Stéphanie, Claris, Olivier, Gaucherand, Pascal, and Doret-Dion, Muriel

Subjects
FETAL growth retardation, MEDICAL screening, SMALL for gestational age, FETAL monitoring, PRENATAL diagnosis
Abstract

Background Fetal Growth restriction (FGR) is the pathological failure of a fetus to reach its biologically determined growth potential. Detection of FGR fetuses is a universally agreed key objective of antenatal care. Antenatal detection of FGR has undeniable benefits, juggling between intensive fetal surveillance and optimized timing of delivery; it reduces adverse perinatal outcomes by up to four-fold. However, FGR is still widely underdiagnosed. We aimed to identify the prevalence of FGR diagnosis in our wards and study the impact of the 2013 published French guidelines on the detection rate of FGR. The secondary objective aimed to highlight the factors of suboptimal screening in the population of non-diagnosed FGR fetuses and emphasize the screening method that led to antenatal diagnosis of FGR. Materials and methods We conducted a retrospective study at a single tertiary maternity center in Lyon-France, the Femme Mère Enfant Hospital, including the exhaustive population of FGR born after 24 + 0 weeks of gestation from 1 January 2011 to 31 December 2017. FGR was defined combining the neonatal and antenatal consensus-based definitions for early and late FGR in absence of congenital anomalies, excluding small for gestational age fetuses. For all FGR fetuses, we compared the antenatal detection rate of FGR during 2011–2013 to 2015–2017, since the French guidelines were published in December 2013. When FGR fetuses underwent an antenatal diagnosis of FGR, we retrospectively collected the characteristics that led to the diagnosis. When fetuses were not diagnosed as FGR, we retrospectively reviewed the implementation of the recommended screening method, enabling to evaluate whether screening was optimal or not. Statistical analysis was performed in July 2018, and statistical significance was regarded as a p-value <.05. Results Over the seven-year period, and among 31,052 newborns, 1020 (3.3%) infants were identified as FGR and met the inclusion criteria. The detection rate of FGR was similar before and after publication of the French Guidelines related to FGR in 2013. Indeed, 50.8% (201/395) FGR were diagnosed between 2011 and 2013 versus 52.6% (245/465) between 2015 and 2017 (p = .59). In the population of non-diagnosed FGR infants, screening was suboptimal in 80%. Symphysis-fundal height (SFH) was not measured in 10.7%, with no difference before and after 2014 (7.3 versus 11.8% p = .11). Ultrasound examination for fetal biometry had not been prescribed in spite of abnormal SFH in 47.7% of undiagnosed FGR infants. Diagnosis has been missed in 11.5% of infants because of misinterpretation of the estimated fetal weight’s centile. Conclusion FGR is widely underdiagnosed. However, the limited performances can partially be explained by the regular misuse of screening method in clinical practice. Despite the systematic third trimester ultrasound screening, the detection rate of FGR was similar to the one reported in the medical literature. The timing of routine third trimester ultrasound in low-risk women may be rethought. [ABSTRACT FROM AUTHOR]

Published
2022
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66. Protocol of controlled odorant stimulation for reducing apnoeic episodes in premature newborns: a randomised open-label Latin-square study with independent evaluation of the main endpoint (PREMODEUR)

Author

Duchamp-Viret, Patricia, primary, Nguyen, Huu Kim, additional, Maucort-Boulch, Delphine, additional, Remontet, Laurent, additional, Guyon, Aurore, additional, Franco, Patricia, additional, Cividjian, Andrei, additional, Thevenet, Marc, additional, Iwaz, Jean, additional, Galletti, Sonia, additional, Kassai, Behrouz, additional, Cornaton, Elise, additional, Plaisant, Franck, additional, Claris, Olivier, additional, and Gauthier-Moulinier, Hélène, additional

Published
2021
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68. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhône Loire, France

Author

Casalegno, Jean-Sebastien, Ploin, Dominique, Cantais, Aymeric, Masson, Elsa, Bard, Emilie, Valette, Martine, Fanget, Remi, Targe, Sandrine Couray, Myar-Dury, Anne-Florence, Doret-Dion, Muriel, Massoud, Mona, Queromes, Gregory, Vanhems, Philippe, Claris, Olivier, Butin, Marine, Pillet, Sylvie, Ader, Florence, Bin, Sylvie, Gaymard, Alexandre, Lina, Bruno, Morfin, Florence, Javouhey, Etienne, Gillet, Yves, Ouziel, Antoine, Tardy, Jean-claude, Gaucherand, Pascal, Panetta, Luc, Massardier, Jerome, Polazzi, Stephanie, Duclos, Antoine, Benchaib, Mehdi, Cartier, Regine, Jourdain, Marine, Ottmann, Michelle, Kramer, Rolf, Fiorini, Sylvie, Rivat, Nathalie, Mekki, Yahia, Fort-Jacquier, Julie, Barral, Maud-Catherine, Noelie, Vey, Haesebaert, Julie, Horvat, Come, Vidoni, Leo, Reynes, Jean-Marc, Eleouet, Jean-Francois, Josset, Laurence, Receveur, Matthieu, Institut des Agents Infectieux [Lyon] (IAI), Hospices Civils de Lyon (HCL), Centre National de Référence des Virus des Infections Respiratoires (dont la Grippe) [Lyon] (CNR - laboratoire associé), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Virology and human respiratory Pathologies - Virology and human respiratory Pathologies (VirPath), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Groupe Immunité des Muqueuses et Agents Pathogènes (GIMAP), Université Jean Monnet - Saint-Étienne (UJM), Hôpital Edouard Herriot [CHU - HCL], Santé publique, épidémiologie et écologie évolutive des maladies infectieuses (PHE3ID), Pôle Information Médicale Evaluation Recherche (IMER), Hôpital de la Croix-Rousse [CHU - HCL], VRS study group in Lyon: Antoine Ouziel, Jean-claude Tardy, Pascal Gaucherand, Luc Panetta, Jerome Massardier, Stephanie Polazzi, Antoine Duclos, Mehdi Benchaib, Regine Cartier, Marine Jourdain, Michelle Ottmann, Rolf Kramer, Sylvie Fiorini, Nathalie Rivat, Yahia Mekki, Julie Fort-Jacquier, Maud-Catherine Barral, Vey Noelie, Julie Haesebaert, Come Horvat, Leo Vidoni, Jean-Marc Reynes, Jean-Francois Eleouet, Laurence Josset, Matthieu Receveur, Reynes, Jean-Marc, Centre National de Référence des Virus des Infections Respiratoires (dont la Grippe) [Lyon] (CNR), Centre International de Recherche en Infectiologie - UMR (CIRI), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne)

Subjects
0301 basic medicine, Pediatrics, Epidemiology, pharmacological interventions, MESH: Hospitalization, MESH: Respiratory Syncytial Virus, Human, disease burden, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Child, 030212 general & internal medicine, Respiratory system, Child, Respiratory Tract Infections, [SDV.MP.VIR] Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Respiratory tract infections, Incidence (epidemiology), RSV, MESH: Infant, Hospitalization, non-pharmacological interventions, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, bronchiolitis, France, Rapid Communication, Adult, medicine.medical_specialty, Respiratory Syncytial Virus Infections, Virus, MESH: Respiratory Syncytial Virus Infections, 03 medical and health sciences, Virology, Lower respiratory tract infection, medicine, Humans, Epidemics, MESH: Epidemics, Disease burden, MESH: Humans, business.industry, SARS-CoV-2, Public Health, Environmental and Occupational Health, Outbreak, COVID-19, Infant, MESH: Adult, medicine.disease, MESH: France, 030104 developmental biology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Bronchiolitis, Respiratory Syncytial Virus, Human, MESH: Respiratory Tract Infections, SARI, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

International audience; The Rhône-Loire metropolitan areas’ 2020/21 respiratory syncytial virus (RSV) epidemic was delayed following the implementation of non-pharmaceutical interventions (NPI), compared with previous seasons. Very severe lower respiratory tract infection incidence among infants ≤ 3 months decreased twofold, the proportion of cases among children aged > 3 months to 5 years increased, and cases among adults > 65 years were markedly reduced. NPI appeared to reduce the RSV burden among at-risk groups, and should be promoted to minimise impact of future RSV outbreaks.

Published
2021
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69. Fetal growth restriction: underdiagnosed condition with non-optimal screening

Author

Atallah, Anthony, Butin, Marine, Moret, Stéphanie, Claris, Olivier, Gaucherand, Pascal, and Doret-Dion, Muriel

Abstract

Fetal Growth restriction (FGR) is the pathological failure of a fetus to reach its biologically determined growth potential. Detection of FGR fetuses is a universally agreed key objective of antenatal care. Antenatal detection of FGR has undeniable benefits, juggling between intensive fetal surveillance and optimized timing of delivery; it reduces adverse perinatal outcomes by up to four-fold. However, FGR is still widely underdiagnosed. We aimed to identify the prevalence of FGR diagnosis in our wards and study the impact of the 2013 published French guidelines on the detection rate of FGR. The secondary objective aimed to highlight the factors of suboptimal screening in the population of non-diagnosed FGR fetuses and emphasize the screening method that led to antenatal diagnosis of FGR. We conducted a retrospective study at a single tertiary maternity center in Lyon-France, the Femme Mère Enfant Hospital, including the exhaustive population of FGR born after 24 + 0 weeks of gestation from 1 January 2011 to 31 December 2017. FGR was defined combining the neonatal and antenatal consensus-based definitions for early and late FGR in absence of congenital anomalies, excluding small for gestational age fetuses. For all FGR fetuses, we compared the antenatal detection rate of FGR during 2011–2013 to 2015–2017, since the French guidelines were published in December 2013. When FGR fetuses underwent an antenatal diagnosis of FGR, we retrospectively collected the characteristics that led to the diagnosis. When fetuses were not diagnosed as FGR, we retrospectively reviewed the implementation of the recommended screening method, enabling to evaluate whether screening was optimal or not. Statistical analysis was performed in July 2018, and statistical significance was regarded as a p-value p = .59). In the population of non-diagnosed FGR infants, screening was suboptimal in 80%. Symphysis-fundal height (SFH) was not measured in 10.7%, with no difference before and after 2014 (7.3 versus 11.8% p = .11). Ultrasound examination for fetal biometry had not been prescribed in spite of abnormal SFH in 47.7% of undiagnosed FGR infants. Diagnosis has been missed in 11.5% of infants because of misinterpretation of the estimated fetal weight’s centile. FGR is widely underdiagnosed. However, the limited performances can partially be explained by the regular misuse of screening method in clinical practice. Despite the systematic third trimester ultrasound screening, the detection rate of FGR was similar to the one reported in the medical literature. The timing of routine third trimester ultrasound in low-risk women may be rethought.

Published
2021
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73. Neurodevelopmental Outcomes after Premedication with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial

Author

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

Published
2021
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74. Early Adjuvant Medication With the mTOR Inhibitor Sirolimus in a Preterm Neonate With Compressive Cystic Lymphatic Malformation

Author

Honnorat, Marion, Viremouneix, Loïc, Ayari, Sonia, Guibaud, Laurent, Coste, Karen, Claris, Olivier, and Butin, Marine

Subjects
sirolimus, mTOR inhibitor, sclerotherapy, Case Report, preterm, Pediatrics, lymphangioma
Abstract

Cystic lymphatic malformations result from an abnormal embryological development of the lymphatic structures. Here we report on a case of a preterm female baby, born at 34 weeks of gestation, with a voluminous cervicofacial cystic lymphatic malformation responsible for an airway obstruction. An mTOR inhibitor, sirolimus, was started from the first day of life, and was combined with iterative sclerotherapy procedures. This case illustrates a safe and successful early administration of sirolimus in a preterm neonate.

Published
2020

75. BURDEN OF HOSPITALIZATION DUE TO RESPIRATORY SYNCYTIAL VIRUS (RSV)-VERY SEVERE ASSOCIATED LOWER RESPIRATORY TRACT INFECTION (VS-ALRI) IN THE FIRST YEAR OF LIFE IN A MAJOR URBAN CITY, LYON, FRANCE. On behalf the VRS Study group in Lyon

Author

C Horvat, L Duclaux-Loras, A Myard-Dury, B Lina, E Javouhey, Y Gillet, J S Casalegno, Ottmann, Michele, Ploin, Dominique, Gaymard, Alexandre, Kramer, Rolf, Benchaib, Mehdi, Yahia Mekki, Javouhey, Etienne, Duclos, Antoine, Gillet, Yves, Polazzi, Stephanie, Lina, Bruno, Vanhems, Philippe, Claris, Olivier, Valette, Martine, Couray-Targe, Sandrine, Massoud, Mona, Cartier, Régine, Josset, Laurence, Butin, Marine, Bin, Sylvie, Horvat, Côme, Jean-Sebastien Casalegno, Jourdain, Marine, Ouziel, Antoine, Anne-Florence Myard-Dury, Doret-Dion, Muriel, Fiorini, Sylvie, Morfin-Sherpa, Florence, Gaucherand, Pascal, Ader, Florence, Rivat, Nathalie, and Lyon, The VRS Study Group In

Published
2020
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76. Very severe RSV-associated respiratory tract infection in children living in a French urban city: Incidence and risk factors (ESPID 2020)

Author

L Duclos-Lauras, L Alexandre, A Paul, T Guichard, E Rault, S Fiorini, N Rivat, Ploin, Dominique, Benchaib, Mehdi, Kramer, Rolf, Yahia Mekki, Duclos, Antoine, Javouhey, Etienne, Gillet, Yves, Lina, Bruno, Vanhems, Philippe, Claris, Olivier, Valette, Martine, Couray-Targe, Sandrine, Massoud, Mona, Cartier, Régine, Lyon, The VRS Study Group In, Morfin-Sherpa, Florence, Ottmann, Michele, Bin, Sylvie, Butin, Marine, Horvat, Côme, Jourdain, Marine, Biot, Blandine, Ouziel, Antoine, Doret-Dion, Muriel, Gaucherand, Pascal, Massardier, Jerome, Anne-Florence Myard-Dury, Polazzi, Stephanie, and Jean-Sebastien Casalegno

Published
2020
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77. Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial

Author

Laborie, Sophie, Denis, Angelique, Horsch, Antje, Occelli, Pauline, Margier, Jennifer, Morisod Harari, Mathilde, Claris, Olivier, Touzet, Sandrine, and Fischer Fumeaux, Celine Julie

Subjects
Adult, Counseling, Male, breastfeeding, Infant, Newborn, nutritional support, Mothers, Paediatrics, Peer Group, Breast Feeding, peer counselling, Intensive Care Units, Neonatal, Protocol, Humans, Female, Infant, Premature
Abstract

Introduction Among preterm infants, mother’s own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. Methods and analysis Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers’ concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother–infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost–consequence at 2 years corrected age will be performed among infants in a French subgroup. Ethics and dissemination French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. Trial registration number NCT03156946

Published
2020

82. Liste des collaborateurs

Author

Amiel-Tison, Claudine, primary, André, Monique, additional, Aujard, Yannick, additional, Aupetit, Laurence, additional, Autret-Leca, Élisabeth, additional, Batard, Christine, additional, Battut, Anne, additional, Beau-Salinas, Frédérique, additional, Beley, Gérard, additional, Casper, Charlotte, additional, Cissoko, Hawar, additional, Claris, Olivier, additional, Debruille, Chantal, additional, Espagne, Sandrine, additional, Feillet, François, additional, Grosse, Camille, additional, Groussin-Weyland, Michelle, additional, Hascoët, Jean-Michel, additional, Hubert, Claire, additional, Huet, Frédéric, additional, Jonville-Bera, Annie-Pierre, additional, Journeau, Pierre, additional, Kuhn, Pierre, additional, Langhendries, Jean-Paul, additional, Lascombes, Pierre, additional, Lejeune, Claude, additional, Locquet, André, additional, McGowan, Jane, additional, Molenat, Françoise, additional, Morville, Patrice, additional, Papageorgiou, Apostolides, additional, Rigo, Jacques, additional, Rouabah, Amira, additional, Rouabah, Mahmoud, additional, Schmit-Ansel, Anne, additional, Simeoni, Umberto, additional, Tchomakov, Dimitar, additional, Teurnier, Frédérique, additional, Toubin, Rose Marie, additional, Truttmann, Anita, additional, Valleur-Masson, Danièle, additional, Vert, Paul, additional, and Voyer, Marcel, additional

Published
2010
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83. Identifying the Target Population for Primary Respiratory Syncytial Virus Two-Step Prevention in Infants: Normative Outcome of Hospitalisation Assessment for Newborns (NOHAN).

Author

Jourdain, Marine, Benchaib, Mehdi, Ploin, Dominique, Gillet, Yves, Javouhey, Etienne, Horvat, Come, Massoud, Mona, Butin, Marine, Claris, Olivier, Lina, Bruno, and Casalegno, Jean-Sebastien

Subjects
RESPIRATORY syncytial virus, NEWBORN screening, INFANTS, MOTHER-infant relationship, BIRTH weight, HUMAN metapneumovirus infection
Abstract

Background: Respiratory syncytial virus (RSV) is the leading cause of acute respiratory infection- related hospitalisations in infants (RSVh). Most of these infants are younger than 6 months old with no known risk factors. An efficient RSVh prevention program should address both mothers and infants, relying on Non-Pharmaceutical (NPI) and Pharmaceutical Interventions (PI). This study aimed at identifying the target population for these two interventions. Methods: Laboratory-confirmed RSV-infected infants hospitalised during the first 6 months of life were enrolled from the Hospices Civils de Lyon birth cohort (2014 to 2018). Clinical variables related to pregnancy and birth (sex, month of birth, birth weight, gestational age, parity) were used for descriptive epidemiology, multivariate logistic regression, and predictive score development. Results: Overall, 616 cases of RSVh in 45,648 infants were identified. Being born before the epidemic season, prematurity, and multiparity were independent predictors of RSVh. Infants born in January or June to August with prematurity and multiparity, and those born in September or December with only one other risk factor (prematurity or multiparity) were identified as moderate-risk, identifying the mothers as candidates for a first-level NPI prevention program. Infants born in September or December with prematurity and multiparity, and those born in October or November were identified as high-risk, identifying the mothers and infants as candidates for a second-level (NPI and PI) intervention. Conclusions: It is possible to determine predictors of RSVh at birth, allowing early enrollment of the target population in a two-level RSV prevention intervention. [ABSTRACT FROM AUTHOR]

Published
2022
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90. A population pharmacokinetic model for escitalopram and its major metabolite in depressive patients during the perinatal period: Prediction of infant drug exposure through breast milk

Author

Weisskopf, Etienne, primary, Guidi, Monia, additional, Fischer, Céline J., additional, Bickle Graz, Myriam, additional, Beaufils, Etienne, additional, Nguyen, Kim An, additional, Morisod Harari, Mathilde, additional, Rouiller, Sylvie, additional, Rothenburger, Sophie, additional, Gaucherand, Pascal, additional, Kassai‐Koupai, Behrouz, additional, Borradori Tolsa, Cristina, additional, Epiney, Manuella, additional, Tolsa, Jean‐François, additional, Vial, Yvan, additional, Hascoët, Jean‐Michel, additional, Claris, Olivier, additional, Eap, Chin B, additional, Panchaud, Alice, additional, and Csajka, Chantal, additional

Published
2020
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91. Neonatal Outcomes for Women at Risk of Preterm Delivery Given Half Dose Versus Full Dose of Antenatal Betamethasone: A Randomized, Multicentre, Double-blind, Placebo-Controlled, Non-inferiority Trial.

Author

Schmitz, Thomas, Doret-Dion, Muriel, Sentilhes, Loic, Parant, Olivier, Claris, Olivier, Renesme, Laurent, Abbal, Julie, Girault, Aude, Torchin, Héloïse, Houllier, Marie, Le Saché, Nolwenn, Vivanti, Alexandre J., De Luca, Daniele, Winer, Norbert, Flamant, Cyril, Thuillier, Claire, Boileau, Pascal, Blanc, Julie, Brevaut, Véronique, and Bouet, Pierre-Emmanuel

Published
2023
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94. Prenatal parental involvement in decision for delivery room management at 22-26 weeks of gestation in France - The EPIPAGE-2 Cohort Study

Author

Levaillant, Cerise, Caeymaex, Laurence, Behal, Hélène, Kaminski, Monique, Diguisto, Caroline, Tosello, Barthélémy, Azria, Elie, Claris, Olivier, Bétrémieux, Pierre, Foix L'Hélias, Laurence, Truffert, Patrick, Gestionnaire, Hal Sorbonne Université, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Intercommunal de Créteil (CHIC), Centre d'Etudes des discours, Images, Textes, Ecrits, Communications (CEDITEC), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université de Lille, Université Sorbonne Paris Cité (USPC), 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), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), EFS, Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, CHU Pontchaillou [Rennes], Service de néonatologie [CHU Trousseau], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), 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 Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], CHU Lille, Centre Hospitalier Régional Universitaire [Lille] [CHRU Lille], METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Centre d'Etudes des discours, Images, Textes, Ecrits, Communications [CEDITEC], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique [CRESS - U1153], Université Claude Bernard Lyon 1 [UCBL], Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-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)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), 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), Groupe hospitalier Paris Saint-Joseph - Hôpital, and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Trousseau [APHP]-Sorbonne Université (SU)

Subjects
Male, Parents, Critical Care and Emergency Medicine, Physiology, Maternal Health, Resuscitation, Decision Making, Social Sciences, Gestational Age, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Pediatrics, Families, Labor and Delivery, Cognition, Pregnancy, Medicine and Health Sciences, Humans, Psychology, Birth Weight, Public Health Surveillance, Children, Delivery Rooms, Body Weight, Infant, Newborn, Cognitive Psychology, Disease Management, Infant, Biology and Life Sciences, Neonates, Obstetrics and Gynecology, Delivery, Obstetric, [SDV.MHEP.GEO] Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Physiological Parameters, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Age Groups, Infant, Extremely Premature, People and Places, Birth, Cognitive Science, Women's Health, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Population Groupings, France, Infants, Research Article, Developmental Biology, Neuroscience
Abstract

International audience; OBJECTIVE: Our main objective was to examine if parental prenatal preferences predict delivery-room management of extremely preterm periviable infants. The secondary objectives were to describe parental involvement and the content of prenatal counseling given to parents for this prenatal decision.DESIGN: Prospective study of neonates liveborn between 22 and 26 weeks of gestation in France in 2011 among the neonates included in the EPIPAGE-2 study.SETTING: 18 centers participating in the "Extreme Prematurity Group" substudy of the EPIPAGE-2 study.PATIENTS: 302 neonates liveborn between 22-26 weeks among which 113 with known parental preferences while parental preferences were unknown or unavailable for 186 and delivery room management was missing for 3.RESULTS: Data on prenatal counseling and parental preferences were collected by a questionnaire completed by professionals who cared for the baby at birth; delivery room (DR) management, classified as stabilization or initiation of resuscitation (SIR) vs comfort care (CC). The 113 neonates studied had a mean (SD) gestational age of 24 (0.1) weeks. Parents of neonates in the CC group preferred SIR less frequently than those with neonates in the SIR group (16% vs 88%, p < .001). After multivariate analysis, preference for SIR was an independent factor associated with this management. Professionals qualified decisions as shared (81%), exclusively medical (16%) or parental (3%). Information was described as medical with no personal opinion (71%), complete (75%) and generally pessimistic (54%).CONCLUSION: Parental involvement in prenatal decision-making did not reach satisfying rates in the studied setting. When available, prenatal parental preference was a determining factor for DR management of extremely preterm neonates. Potential biases in the content of prenatal counselling given to parents need to be evaluated.

Published
2019
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95. Risk factors associated with severe RSV LRTI in the first year of life in Lyon (France): a hospital-based cohort study (ESPID congress 2019)

Author

Biot, Blandine, Ploin, Dominique, Ouziel, Antoine, Javouhey, Etienne, Claris, Olivier, Butin, Marine, Doret-Dion, Muriel, Gaucherand, Pascal, Massardier, Jerome, Couray-Targe, Sandrine, Anne-Florence Myard-Dury, Vanhems, Philippe, Hilliquin, Delphine, Bin, Sylvie, Massoud, Mona, Duclos, Antoine, Polazzi, Stephanie, Benchaib, Mehdi, Gardie, Anna, Cartier, Régine, Lina, Bruno, Morfin, Florence, Valette, Martine, Kramer, Rolf, Yahia Mekki, Fiorini, Sylvie, Ottmann, Michele, Rivat, Nathalie, Jean-Sebastien Casalegno, Lyon, The VRS Study Group In, and Gillet, Yves

Published
2019
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99. 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 Lühr, Pellicer, Adelina, Gluud, Christian, Dempsey, Eugene, Mintzer, Jonathan, Hyttel-Sørensen, Simon, Heuchan, Anne Marie, Hagmann, Cornelia, Ergenekon, Ebru, Dimitriou, Gabriel, Pichler, Gerhard, Naulaers, Gunnar, Cheng, Guoqiang, Guimarães, Hercilia, Tkaczyk, Jakub, Kreutzer, Karen B., Fumagalli, Monica, Claris, Olivier, Lemmers, Petra, Fredly, Siv, Szczapa, Tomasz, Austin, Topun, Jakobsen, Janus Christian, Greisen, Gorm, Hansen, Mathias Lühr, Pellicer, Adelina, Gluud, Christian, Dempsey, Eugene, Mintzer, Jonathan, Hyttel-Sørensen, Simon, Heuchan, Anne Marie, Hagmann, Cornelia, Ergenekon, Ebru, Dimitriou, Gabriel, Pichler, Gerhard, Naulaers, Gunnar, Cheng, Guoqiang, Guimarães, Hercilia, Tkaczyk, Jakub, Kreutzer, Karen B., Fumagalli, Monica, Claris, Olivier, Lemmers, Petra, Fredly, Siv, Szczapa, Tomasz, Austin, Topun, Jakobsen, Janus Christian, and Greisen, Gorm

Abstract

Background: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. Methods/design: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we in

Published
2019

100. Detailed statistical analysis plan for the SafeBoosC III trial:A multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

Author

Hansen, Mathias Lühr, Pellicer, Adelina, Gluud, Christian, Dempsey, Eugene, Mintzer, Jonathan, Hyttel-Sorensen, Simon, Heuchan, Anne Marie, Hagmann, Cornelia, Dimitriou, Gabriel, Pichler, Gerhard, Naulaers, Gunnar, Cheng, Guoqiang, Vilan, Ana, Tkaczyk, Jakub, Kreutzer, Karen B., Fumagalli, Monica, Claris, Olivier, Fredly, Siv, Szczapa, Tomasz, Lange, Theis, Jakobsen, Janus Christian, Greisen, Gorm, Hansen, Mathias Lühr, Pellicer, Adelina, Gluud, Christian, Dempsey, Eugene, Mintzer, Jonathan, Hyttel-Sorensen, Simon, Heuchan, Anne Marie, Hagmann, Cornelia, Dimitriou, Gabriel, Pichler, Gerhard, Naulaers, Gunnar, Cheng, Guoqiang, Vilan, Ana, Tkaczyk, Jakub, Kreutzer, Karen B., Fumagalli, Monica, Claris, Olivier, Fredly, Siv, Szczapa, Tomasz, Lange, Theis, Jakobsen, Janus Christian, and Greisen, Gorm

Abstract

Background: Infants born extremely preterm are at high risk of dying or suffering from severe brain injuries. Treatment guided by monitoring of cerebral oxygenation may reduce the risk of death and neurologic complications. The SafeBoosC III trial evaluates the effects of treatment guided by cerebral oxygenation monitoring versus treatment as usual. This article describes the detailed statistical analysis plan for the main publication, with the aim to prevent outcome reporting bias and data-driven analyses. Methods/design: The SafeBoosC III trial is an investigator-initiated, randomised, multinational, pragmatic phase III trial with a parallel group structure, designed to investigate the benefits and harms of treatment based on cerebral near-infrared spectroscopy monitoring compared with treatment as usual. Randomisation will be 1:1 stratified for neonatal intensive care unit and gestational age (lower gestational age (< 26 weeks) compared to higher gestational age (≥ 26 weeks)). The primary outcome is a composite of death or severe brain injury at 36 weeks postmenstrual age. Primary analysis will be made on the intention-to-treat population for all outcomes, using mixed-model logistic regression adjusting for stratification variables. In the primary analysis, the twin intra-class correlation coefficient will not be considered. However, we will perform sensitivity analyses to address this. Our simulation study suggests that the inclusion of multiple births is unlikely to significantly affect our assessment of intervention effects, and therefore we have chosen the analysis where the twin intra-class correlation coefficient will not be considered as the primary analysis. Discussion: In line with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines, we have developed and published this statistical analysis plan for the SafeBoosC III trial, prior to any data analysis. Trial registration: ClinicalTrials.org

Published
2019

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