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4. Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)

Author

Poppe, Jarinda A., Flint, Robert B., Smits, Anne, Willemsen, Sten P., Storm, Kelly K., Nuytemans, Debbie H., Onland, Wes, Poley, Marten J., de Boode, Willem P., Carkeek, Katherine, Cassart, Vincent, Cornette, Luc, Dijk, Peter H., Hemels, Marieke A. C., Hermans, Isabelle, Hütten, Matthias C., Kelen, Dorottya, de Kort, Ellen H. M., Kroon, André A., Lefevere, Julie, Plaskie, Katleen, Stewart, Breanne, Voeten, Michiel, van Weissenbruch, Mirjam M., Williams, Olivia, Zonnenberg, Inge A., Lacaze-Masmonteil, Thierry, Pas, Arjan B.te, Reiss, Irwin K. M., van Kaam, Anton H., Allegaert, Karel, Hutten, G. Jeroen, and Simons, Sinno H. P.

Published
2023
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5. NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): evaluation of a national guideline on management of neonatal catheter-related venous thrombosis

Author

van Ommen, C. Heleen, Bergman, Klasien A., Boerma, Marit, Bouma, Heleen A., Donker, Albertine E., Gouvernante, Melissa, Hulzebos, Christian V., Khandour, Dalila, Knol, Ronny, Raets, Marlou A., Liem, K. Djien, van Lingen, Richard A., van de Loo, Moniek, Lopriore, Enrico, van der Putten, Mayke, Sol, Jeanine J., Suijker, Monique H., Vijlbrief, Daniel C., Visser, Remco, and van Weissenbruch, Mirjam M.

Published
2023
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6. Association between duration of early empiric antibiotics and necrotizing enterocolitis and late-onset sepsis in preterm infants: a multicenter cohort study

Author

Dierikx, Thomas H., Deianova, Nancy, Groen, Jip, Vijlbrief, Daniel C., Hulzebos, Christian, de Boode, Willem P., d’Haens, Esther J., Cossey, Veerle, Kramer, Boris W., van Weissenbruch, Mirjam M., de Jonge, Wouter J., Benninga, Marc A., van den Akker, Chris H., van Kaam, Anton H., de Boer, Nanne K. H., Visser, Douwe H., Niemarkt, Hendrik J., and de Meij, Tim G. J.

Published
2022
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7. Pharmacokinetic/Pharmacodynamic Modelling of Allopurinol, its Active Metabolite Oxypurinol, and Biomarkers Hypoxanthine, Xanthine and Uric Acid in Hypoxic-Ischemic Encephalopathy Neonates

Author

Chu, Wan-Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J. N. L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P. C., Allegaert, Karel, and Huitema, Alwin D. R.

Published
2022
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11. Fecal microbiota and volatile metabolome pattern alterations precede late-onset meningitis in preterm neonates

Author

Frerichs, Nina M, primary, Deianova, Nancy, additional, el Manouni el Hassani, Sofia, additional, Acharjee, Animesh, additional, Quraishi, Mohammed Nabil, additional, de Boode, Willem P, additional, Cossey, Veerle, additional, Hulzebos, Christian V, additional, van Kaam, Anton H, additional, Kramer, Boris W, additional, d’Haens, Esther, additional, de Jonge, Wouter J, additional, Vijlbrief, Daniel C, additional, van Weissenbruch, Mirjam M, additional, Daulton, Emma, additional, Wicaksono, Alfian N, additional, Covington, James A, additional, Benninga, Marc A, additional, de Boer, Nanne K H, additional, van Goudoever, Johannes B, additional, Niemarkt, Hendrik J, additional, and de Meij, Tim G J, additional

Published
2024
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13. Predictive factors for surgical treatment in preterm neonates with necrotizing enterocolitis: a multicenter case-control study

Author

el Manouni el Hassani, Sofia, Niemarkt, Hendrik J., Derikx, Joep P. M., Berkhout, Daniel J. C., Ballón, Andrea E., de Graaf, Margot, de Boode, Willem P., Cossey, Veerle, Hulzebos, Christian V., van Kaam, Anton H., Kramer, Boris W., van Lingen, Richard A., Vijlbrief, Daniel C., van Weissenbruch, Mirjam M., Benninga, Marc A., de Boer, Nanne K. H., and de Meij, Tim G. J.

Published
2021
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16. Late-onset Sepsis in Preterm Infants Can Be Detected Preclinically by Fecal Volatile Organic Compound Analysis : A Prospective, Multicenter Cohort Study

Author

Berkhout, Daniel J. C., van Keulen, Britt J., Niemarkt, Hendrik J., Bessem, Jet R., de Boode, Willem P., Cossey, Veerle, Hoogenes, Neil, Hulzebos, Christiaan V., Klaver, Ellen, Andriessen, Peter, van Kaam, Anton H., Kramer, Boris W., van Lingen, Richard A., Schouten, Aaron, van Goudoever, Johannes B., Vijlbrief, Daniel C., van Weissenbruch, Mirjam M., Covington, Alfian N. Wicaksono, Covington, James A., Benninga, Marc A., de Boer, Nanne K. H., and de Meij, Tim G. J.

Published
2019

18. Preclinical Detection of Non-catheter Related Late-onset Sepsis in Preterm Infants by Fecal Volatile Compounds Analysis: A Prospective, Multi-center Cohort Study

Author

Berkhout, Daniel J.C., Niemarkt, Hendrik J., Andriessen, Peter, Vijlbrief, Daniel C., Bomers, Marije K., Cossey, Veerle, Hulzebos, Christian V., van Kaam, Anton H., Kramer, Boris W., van Lingen, Richard A., Wicaksono, Alfian N., Covington, James A., van Weissenbruch, Mirjam M., Benninga, Marc A., de Boer, Nanne K.H., and de Meij, Tim G.J.

Published
2020
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19. Identifying effect modifiers of systemic hydrocortisone treatment initiated 7–14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial

Author

Halbmeijer, Nienke Marjolein, primary, Sonnaert, Michel, additional, Swarte, Renate M, additional, Koopman-Esseboom, Corine, additional, van Stuijvenberg, Margriet, additional, Mulder-de Tollenaer, Susanne, additional, Tan, Ratna N G B, additional, Mohns, Thilo, additional, Bruneel, Els, additional, Steiner, Katerina, additional, Kramer, Boris W, additional, Debeer, Anne, additional, van Weissenbruch, Mirjam M, additional, Marechal, Yoann, additional, Blom, Henry, additional, Plaskie, Katleen, additional, Offringa, Martin, additional, Merkus, Maruschka P, additional, Onland, Wes, additional, Leemhuis, Aleid G, additional, and van Kaam, Anton H, additional

Published
2023
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20. Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age

Author

SToP-BPD Study Group, Halbmeijer, Nienke Marjolein, Onland, Wes, Cools, Filip, Swarte, Renate M, van der Heide-Jalving, Marja, Dijk, Peter, Mulder-de Tollenaer, Susanne, Tan, Ratna N G B, Mohns, Thilo, Bruneel, Els, van Heijst, Arno F J, Kramer, Boris, Debeer, Anne, van Weissenbruch, Mirjam M, Marechal, Yoann, Blom, Henry, Plaskie, Katleen, Offringa, Martin, van Wassenaer-Leemhuis, Aleid G, van Kaam, Anton H, Aarnoudse-Moens, Cornelieke S H, Neonatology, Brussels Heritage Lab, UZB Other, Clinical sciences, Growth and Development, STOP-BPD Study Group, RS: MHeNs - R3 - Neuroscience, RS: GROW - R4 - Reproductive and Perinatal Medicine, and MUMC+: MA Medische Staf Kindergeneeskunde (9)

Subjects
BIRTH, MORTALITY, SCHOOL-AGE, MULTICENTER, Obstetrics and Gynecology, General Medicine, BRONCHOPULMONARY DYSPLASIA, THERAPY, neonatology, DEXAMETHASONE, Pediatrics, Perinatology and Child Health, SURVIVAL, Human medicine, Pediatrics, Perinatology, and Child Health, CHILDREN BORN, Child development, INITIATED 7
Abstract

ObjectiveTo report the parent-reported behavioural outcomes of infants included in the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants study at 2 years’ corrected age (CA).DesignRandomised placebo-controlled trial.SettingDutch and Belgian neonatal intensive care units.PatientsInfants born InterventionInfants were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).Main outcome measuresParent-reported behavioural outcomes at 2 years’ CA assessed with the Child Behavior Checklist (CBCL 1½−5).ResultsParents completed the CBCL of 183 (70% (183/262)) infants (hydrocortisone group, n=96; placebo group, n=87). Multiple imputation was used to account for missing data. Infants with critically elevated T-scores (>55) were found in 22.9%, 19.1% and 29.4% of infants for total, internalising and externalising problems, respectively; these scores were not significantly different between groups (mean difference −1.52 (95% CI −4.00 to 0.96), −2.40 (95% CI −4.99 to 0.20) and −0.81 (95% CI −3.40 to 1.77), respectively). In the subscales, we found a significantly lower T-score for anxiety problems in the hydrocortisone group (mean difference −1.26, 95% CI −2.41 to –0.12).ConclusionThis study found high rates of behaviour problems at 2 years’ CA following very preterm birth, but these problems were not associated with hydrocortisone treatment initiated between 7 and 14 days after birth in ventilated preterm infants.Trial registration numberNTR2768; EudraCT 2010-023777-19.

Published
2023
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21. Doxapram versus placebo in preterm newborns:a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)

Author

Poppe, Jarinda A., Flint, Robert B., Smits, Anne, Willemsen, Sten P., Storm, Kelly K., Nuytemans, Debbie H., Onland, Wes, Poley, Marten J., de Boode, Willem P., Carkeek, Katherine, Cassart, Vincent, Cornette, Luc, Dijk, Peter H., Hemels, Marieke A.C., Hermans, Isabelle, Hütten, Matthias C., Kelen, Dorottya, de Kort, Ellen H.M., Kroon, André A., Lefevere, Julie, Plaskie, Katleen, Stewart, Breanne, Voeten, Michiel, van Weissenbruch, Mirjam M., Williams, Olivia, Zonnenberg, Inge A., Lacaze-Masmonteil, Thierry, Pas, Arjan B.te, Reiss, Irwin K.M., van Kaam, Anton H., Allegaert, Karel, Hutten, G. Jeroen, Simons, Sinno H.P., Poppe, Jarinda A., Flint, Robert B., Smits, Anne, Willemsen, Sten P., Storm, Kelly K., Nuytemans, Debbie H., Onland, Wes, Poley, Marten J., de Boode, Willem P., Carkeek, Katherine, Cassart, Vincent, Cornette, Luc, Dijk, Peter H., Hemels, Marieke A.C., Hermans, Isabelle, Hütten, Matthias C., Kelen, Dorottya, de Kort, Ellen H.M., Kroon, André A., Lefevere, Julie, Plaskie, Katleen, Stewart, Breanne, Voeten, Michiel, van Weissenbruch, Mirjam M., Williams, Olivia, Zonnenberg, Inge A., Lacaze-Masmonteil, Thierry, Pas, Arjan B.te, Reiss, Irwin K.M., van Kaam, Anton H., Allegaert, Karel, Hutten, G. Jeroen, and Simons, Sinno H.P.

Abstract

Background: Apnoea of prematurity (AOP) is one of the most common diagnoses among preterm infants. AOP often leads to hypoxemia and bradycardia which are associated with an increased risk of death or disability. In addition to caffeine therapy and non-invasive respiratory support, doxapram might be used to reduce hypoxemic episodes and the need for invasive mechanical ventilation in preterm infants, thereby possibly improving their long-term outcome. However, high-quality trials on doxapram are lacking. The DOXA-trial therefore aims to investigate the safety and efficacy of doxapram compared to placebo in reducing the composite outcome of death or severe disability at 18 to 24 months corrected age. Methods: The DOXA-trial is a double blinded, multicentre, randomized, placebo-controlled trial conducted in the Netherlands, Belgium and Canada. A total of 396 preterm infants with a gestational age below 29 weeks, suffering from AOP unresponsive to non-invasive respiratory support and caffeine will be randomized to receive doxapram therapy or placebo. The primary outcome is death or severe disability, defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness, at 18–24 months corrected age. Secondary outcomes are short-term neonatal morbidity, including duration of mechanical ventilation, bronchopulmonary dysplasia and necrotising enterocolitis, hospital mortality, adverse effects, pharmacokinetics and cost-effectiveness. Analysis will be on an intention-to-treat principle. Discussion: Doxapram has the potential to improve neonatal outcomes by improving respiration, but the safety concerns need to be weighed against the potential risks of invasive mechanical ventilation. It is unknown if the use of doxapram improves the long-term outcome. This forms the clinical equipoise of the current trial. This international, multicentre trial will provide the needed high-quality evidence on the e

Published
2023

22. NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT):evaluation of a national guideline on management of neonatal catheter-related venous thrombosis

Author

Sol, Jeanine J., van de Loo, Moniek, Bergman, Klasien A., Boerma, Marit, Bouma, Heleen A., Donker, Albertine E., Gouvernante, Melissa, Hulzebos, Christian V., Khandour, Dalila, Knol, Ronny, Raets, Marlou A., Liem, K. Djien, van Lingen, Richard A., Lopriore, Enrico, van der Putten, Mayke, Suijker, Monique H., Vijlbrief, Daniel C., Visser, Remco, van Weissenbruch, Mirjam M., van Ommen, C. Heleen, Sol, Jeanine J., van de Loo, Moniek, Bergman, Klasien A., Boerma, Marit, Bouma, Heleen A., Donker, Albertine E., Gouvernante, Melissa, Hulzebos, Christian V., Khandour, Dalila, Knol, Ronny, Raets, Marlou A., Liem, K. Djien, van Lingen, Richard A., Lopriore, Enrico, van der Putten, Mayke, Suijker, Monique H., Vijlbrief, Daniel C., Visser, Remco, van Weissenbruch, Mirjam M., and van Ommen, C. Heleen

Abstract

Background: In critically ill (preterm) neonates, catheter-related venous thromboembolism (CVTE) can be a life-threatening complication. Evidence on optimal management in the literature is lacking. In the Netherlands, a consensus-based national management guideline was developed to create uniform CVTE management. Objectives: To evaluate the efficacy and safety of the national guideline. Methods: This prospective, multicenter, observational study included all infants aged ≤6 months with CVTE in the Netherlands between 2014 and 2019. CVTE was divided into thrombosis in veins and that in the right atrium, with their own treatment algorithms. The primary outcomes were recurrent venous thrombotic events (VTEs) and/or death due to CVTE as well as major bleeding. Results: Overall, 115 neonates were included (62% male; 79% preterm). The estimated incidence of CVTE was 4.0 per 1000 neonatal intensive care unit admissions. Recurrent thrombosis occurred in 2 (1.7%) infants and death due to CVTE in 1 (0.9%) infant. Major bleeding developed in 9 (7.8%) infants: 2 of 7 (29%) on recombinant tissue plasminogen activator, which was given for high-risk right-atrium thrombosis, and 7 of 63 (11%) on low-molecular-weight heparin (LMWH). Five of the 7 bleedings because of LMWH were complications of subcutaneous catheter use for LMWH administration. Conclusion: The management of neonatal CVTE according to the Dutch CVTE management guideline led to a low incidence of recurrent VTEs and death due to VTEs. Major bleeding occurred in 7.8% of the infants. Specific guideline adjustments may improve efficacy and, especially, safety of CVTE management in neonates.

Published
2023

23. Fecal Volatile Metabolomics Predict Gram-Negative Late-Onset Sepsis in Preterm Infants: A Nationwide Case-Control Study

Author

MS Neonatologie, Child Health, Frerichs, Nina M, El Manouni El Hassani, Sofia, Deianova, Nancy, van Weissenbruch, Mirjam M, van Kaam, Anton H, Vijlbrief, Daniel C, van Goudoever, Johannes B, Hulzebos, Christian V, Kramer, Boris W, d'Haens, Esther J, Cossey, Veerle, de Boode, Willem P, de Jonge, Wouter J, Wicaksono, Alfian N, Covington, James A, Benninga, Marc A, de Boer, Nanne K H, Niemarkt, Hendrik J, de Meij, Tim G J, MS Neonatologie, Child Health, Frerichs, Nina M, El Manouni El Hassani, Sofia, Deianova, Nancy, van Weissenbruch, Mirjam M, van Kaam, Anton H, Vijlbrief, Daniel C, van Goudoever, Johannes B, Hulzebos, Christian V, Kramer, Boris W, d'Haens, Esther J, Cossey, Veerle, de Boode, Willem P, de Jonge, Wouter J, Wicaksono, Alfian N, Covington, James A, Benninga, Marc A, de Boer, Nanne K H, Niemarkt, Hendrik J, and de Meij, Tim G J

Published
2023

24. Identifying effect modifiers of systemic hydrocortisone treatment initiated 7–14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial.

Author

Halbmeijer, Nienke Marjolein, Sonnaert, Michel, Swarte, Renate M., Koopman-Esseboom, Corine, van Stuijvenberg, Margriet, Tollenaer, Susanne Mulder-de, Tan, Ratna N. G. B., Mohns, Thilo, Bruneel, Els, Steiner, Katerina, Kramer, Boris W., Debeer, Anne, van Weissenbruch, Mirjam M., Marechal, Yoann, Blom, Henry, Plaskie, Katleen, Offringa, Martin, Merkus, Maruschka P., Onland, Wes, and Leemhuis, Aleid G.

Published
2024
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25. Duration of Neonatal Antibiotic Exposure in Preterm Infants in Association with Health and Developmental Outcomes in Early Childhood

Author

Deianova, Nancy, primary, de Boer, Nanne K., additional, Aoulad Ahajan, Hafsa, additional, Verbeek, Cilla, additional, Aarnoudse-Moens, Cornelieke S. H., additional, Leemhuis, Aleid G., additional, van Weissenbruch, Mirjam M., additional, van Kaam, Anton H., additional, Vijbrief, Daniel C., additional, Hulzebos, Chris V., additional, Giezen, Astrid, additional, Cossey, Veerle, additional, de Boode, Willem P., additional, de Jonge, Wouter J., additional, Benninga, Marc A., additional, Niemarkt, Hendrik J., additional, and de Meij, Tim G. J., additional

Published
2023
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29. Fecal Volatile Metabolomics Predict Gram-Negative Late-Onset Sepsis in Preterm Infants: A Nationwide Case-Control Study

Author

Frerichs, Nina M., primary, el Manouni el Hassani, Sofia, additional, Deianova, Nancy, additional, van Weissenbruch, Mirjam M., additional, van Kaam, Anton H., additional, Vijlbrief, Daniel C., additional, van Goudoever, Johannes B., additional, Hulzebos, Christian V., additional, Kramer, Boris. W., additional, d’Haens, Esther J., additional, Cossey, Veerle, additional, de Boode, Willem P., additional, de Jonge, Wouter J., additional, Wicaksono, Alfian N., additional, Covington, James A., additional, Benninga, Marc A., additional, de Boer, Nanne K. H., additional, Niemarkt, Hendrik J., additional, and de Meij, Tim G. J., additional

Published
2023
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30. Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years’ corrected age: follow-up of a randomised clinical trial

Author

Halbmeijer, Nienke Marjolein, primary, Onland, Wes, additional, Cools, Filip, additional, Swarte, Renate M, additional, van der Heide-Jalving, Marja, additional, Dijk, Peter, additional, Mulder-de Tollenaer, Susanne, additional, Tan, Ratna N G B, additional, Mohns, Thilo, additional, Bruneel, Els, additional, van Heijst, Arno F J, additional, Kramer, Boris, additional, Debeer, Anne, additional, van Weissenbruch, Mirjam M, additional, Marechal, Yoann, additional, Blom, Henry, additional, Plaskie, Katleen, additional, Offringa, Martin, additional, van Wassenaer-Leemhuis, Aleid G, additional, van Kaam, Anton H, additional, and Aarnoudse-Moens, Cornelieke S H, additional

Published
2023
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33. Clinical predictors of bacteraemia in neonates with suspected early-onset sepsis in Malawi: a prospective cohort study

Author

de Baat, Tessa, primary, Lester, Rebecca, additional, Ghambi, Lugano, additional, Twabi, Hussein H, additional, Nielsen, Maryke, additional, Gordon, Stephen B, additional, van Weissenbruch, Mirjam M, additional, Feasey, Nicholas A, additional, Dube, Queen, additional, Kawaza, Kondwani, additional, and Iroh Tam, Pui-Ying, additional

Published
2022
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34. Motor Testing at 1 Year Improves the Prediction of Motor and Mental Outcome at 2 Years after Perinatal Hypoxic-Ischaemic Encephalopathy

Author

van Schie, Petra Em, Becher, Jules G., Dallmeijer, Annet J., Barkhof, Frederik, van Weissenbruch, Mirjam M., and Vermeulen, R. Jeroen

Abstract

Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12 females; mean gestational age 40.2 wk, SD 1.4; mean birthweight 3217g, SD 435) participating in a prospective cohort study of HIE. The predictive value of three motor tests (Alberta Infant Motor Scale [AIMS], BSID-II, and the Neurological Optimality Score [NOS]) at 1 year was analysed, in addition to predictions based on neonatal Sarnat staging and magnetic resonance imaging (MRI). Poor motor test results were defined as an AIMS z-score of less than -2, a psychomotor developmental index of the BSID-II of less than 70, or a NOS of less than 26. Poor motor and poor mental outcome at 2 years was defined as a psychomotor developmental index or mental developmental index of the BSID-II of less than 70. Results: Twelve children, all with Sarnat grade II, had a poor motor outcome and 12 children, of whom one had Sarnat grade I, had a poor mental outcome at 2 years. Nine children had cerebral palsy, of whom five had quadriplegia, three had dyskinesia, and one had hemiplegia. Poor motor tests at 1 year increased the probability of a poor motor outcome from 71% (range 92 to 100%), and a poor mental outcome from 59% (range 77 to 100%) in children with Sarnat grade II and abnormal MRI, assessed with the AIMS and BSID-II or NOS respectively. Interpretation: Additional motor testing at 1 year improves the prediction of motor and mental outcome at 2 years in children with Sarnat grade II and abnormal MRI. (Contains 5 tables.)

Published
2010
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39. NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): evaluation of a national guideline on management of neonatal catheter-related thrombosis

Author

Sol, Jeanine J., van de Loo, Moniek, Boerma, Marit, Bergman, Klasien A., Donker, Albertine E., van der Hoeven, Mark A. H. B. M., Hulzebos, Christiaan V., Knol, Ronny, Djien Liem, K., van Lingen, Richard A., Lopriore, Enrico, Suijker, Monique H., Vijlbrief, Daniel C., Visser, Remco, Veening, Margreet A., van Weissenbruch, Mirjam M., and van Ommen, C. Heleen

Published
2018
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40. Pharmacokinetic/Pharmacodynamic Modelling of Allopurinol, its Active Metabolite Oxypurinol, and Biomarkers Hypoxanthine, Xanthine and Uric Acid in Hypoxic-Ischemic Encephalopathy Neonates

Author

Chu, Wan Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J.N.L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P.C., Allegaert, Karel, Huitema, Alwin D.R., Chu, Wan Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J.N.L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P.C., Allegaert, Karel, and Huitema, Alwin D.R.

Abstract

Background: Allopurinol, an xanthine oxidase (XO) inhibitor, is a promising intervention that may provide neuroprotection for neonates with hypoxic-ischemic encephalopathy (HIE). Currently, a double-blind, placebo-controlled study (ALBINO, NCT03162653) is investigating the neuroprotective effect of allopurinol in HIE neonates. Objective: The aim of the current study was to establish the pharmacokinetics (PK) of allopurinol and oxypurinol, and the pharmacodynamics (PD) of both compounds on hypoxanthine, xanthine, and uric acid in HIE neonates. The dosage used and the effect of allopurinol in this population, either or not undergoing therapeutic hypothermia (TH), were evaluated. Methods: Forty-six neonates from the ALBINO study and two historical clinical studies were included. All doses were administered on the first day of life. In the ALBINO study (n = 20), neonates received a first dose of allopurinol 20 mg/kg, and, in the case of TH (n = 13), a second dose of allopurinol 10 mg/kg. In the historical cohorts (n = 26), neonates (all without TH) received two doses of allopurinol 20 mg/kg in total. Allopurinol and oxypurinol population PK, and their effects on inhibiting conversions of hypoxanthine and xanthine to uric acid, were assessed using nonlinear mixed-effects modelling. Results: Allopurinol and oxypurinol PK were described by two sequential one-compartment models with an autoinhibition effect on allopurinol metabolism by oxypurinol. For allopurinol, clearance (CL) was 0.83 L/h (95% confidence interval [CI] 0.62–1.09) and volume of distribution (Vd) was 2.43 L (95% CI 2.25–2.63). For metabolite oxypurinol, CL and Vd relative to a formation fraction (fm) were 0.26 L/h (95% CI 0.23–0.3) and 11 L (95% CI 9.9–12.2), respectively. No difference in allopurinol and oxypurinol CL was found between TH and non-TH patients. The effect of allopurinol and oxypurinol on XO inhibition was described by a turnover

Published
2022

41. Association between duration of early empiric antibiotics and necrotizing enterocolitis and late-onset sepsis in preterm infants: a multicenter cohort study

Author

MS Neonatologie, Child Health, Dierikx, Thomas H, Deianova, Nancy, Groen, Jip, Vijlbrief, Daniel C, Hulzebos, Christian, de Boode, Willem P, d'Haens, Esther J, Cossey, Veerle, Kramer, Boris W. W., van Weissenbruch, Mirjam M, de Jonge, Wouter J, Benninga, Marc A, van den Akker, Chris H, van Kaam, Anton H, de Boer, Nanne K H, Visser, Douwe H, Niemarkt, Hendrik J, de Meij, Tim G J, MS Neonatologie, Child Health, Dierikx, Thomas H, Deianova, Nancy, Groen, Jip, Vijlbrief, Daniel C, Hulzebos, Christian, de Boode, Willem P, d'Haens, Esther J, Cossey, Veerle, Kramer, Boris W. W., van Weissenbruch, Mirjam M, de Jonge, Wouter J, Benninga, Marc A, van den Akker, Chris H, van Kaam, Anton H, de Boer, Nanne K H, Visser, Douwe H, Niemarkt, Hendrik J, and de Meij, Tim G J

Published
2022

42. Getting a grip in the middle of chaos: Preparing for preterm parenthood during a high-risk pregnancy – Parental experiences and needs

Author

Neonatologie Zorg, Child Health, Infection & Immunity, MS Neonatologie, Ruhe, Kiki, van den Hoogen, Agnes, Bröring-Starre, Tinka, Wielenga, Joke M., van Weissenbruch, Mirjam M., Neonatologie Zorg, Child Health, Infection & Immunity, MS Neonatologie, Ruhe, Kiki, van den Hoogen, Agnes, Bröring-Starre, Tinka, Wielenga, Joke M., and van Weissenbruch, Mirjam M.

Published
2022

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