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3. Exposure to clinical stressors during NICU admission in preterm infants

Author

Meesters, Naomi J., van den Bosch, Gerbrich E., Tataranno, Maria Luisa, van den Akker, Chris H. P., van Ganzewinkel, Christ-jan, Barge, Judith A. ten, Schuerman, Frank A. B. A., van Zanten, Henriette, de Boode, Willem P., Raets, Marlou M. A., Dijk, Peter H., van Rosmalen, Joost, Vermeulen, Marijn J., Onland, Wes, Haverman, Lotte, Reiss, Irwin K. M., van Kaam, Anton H., Benders, Manon, van Dijk, Monique, and Simons, Sinno H. P.

Published
2025
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4. Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Author

Willemsen, Sten P., Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L. J., Lopriore, Enrico, Onland, Wes, de Boode, Willem P., van Kaam, Anton H., Nuytemans, Debbie H., Reiss, Irwin K. M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E. M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., te Pas, Arjan B., and Vermeulen, Marijn J.

Published
2024
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5. Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial

Author

Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Onland, Wes, Vermeulen, Marijn J., de Boode, Willem P., van Kaam, Anton H., Lopriore, Enrico, Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., d’Haens, Esther J., Hulzebos, Christian V., Bouma, Helene A., van Sambeeck, Sam J., Niemarkt, Hendrik J., van der Putten, Mayke E., Lebon, Tinta, Zonnenberg, Inge A., Nuytemans, Debbie H., Willemsen, Sten P., Polglase, Graeme R., Steggerda, Sylke J., Hooper, Stuart B., and te Pas, Arjan B.

Published
2025
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9. OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction: results of a large multicenter cohort study (the OPTICORE study)

Author

van de Meent, Mette, Ganzevoort, Wessel, Gordijn, Sanne J., Kooi, Elisabeth M.W., Onland, Wes, Duvekot, Johannes J., van der Wilk, Eline, Kornelisse, René F., Al-Nasiry, Salwan, Jellema, Reint, Knol, H. Marieke, Manten, Gwendolyn T.R., Mulder-de Tollenaer, Susanne M., Derks, Jan B., Groenendaal, Floris, Bekker, Mireille N., Schuit, Ewoud, Lely, A. Titia, and Kooiman, Judith

Published
2024
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12. 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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17. Association between bronchopulmonary dysplasia severity and its risk factors and long-term outcomes in three definitions: a historical cohort study.

Author

Katz, Trixie A., van Kaam, Anton H., Zuithoff, Nicolaas P. A., Mugie, S. M., Beuger, Sabine, Blok, Geert Jan, van Kempen, Anne A. M. W., van Laerhoven, Henriëtte, Lutterman, Claire A. M., Rijpert, Maarten, Schiering, Irene A., Ran, Nicolien C., Visser, Fenna, van Straaten, Els, Aarnoudse-Moens, Cornelieke S. H., van Wassenaer-Leemhuis, Aleid G., and Onland, Wes

Subjects
SMALL for gestational age, PATENT ductus arteriosus, LOW birth weight, NEONATAL intensive care units, CHILDREN with cerebral palsy, NEONATAL nursing, PEER review of students
Published
2025
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18. Severity of Bronchopulmonary Dysplasia and Neurodevelopmental Outcome at 2 and 5 Years Corrected Age

Author

Katz, Trixie A., Vliegenthart, Roseanne J.S., Aarnoudse-Moens, Cornelieke S.H., Leemhuis, Aleid G., Beuger, Sabine, Blok, Geert Jan, van Brakel, Monique J.M., van den Heuvel, Maria E.N., van Kempen, Anne A.M.W., Lutterman, Claire, Rijpert, Maarten, Schiering, Irene A., Ran, Nicolien C., Visser, Fenna, Wilms, Janneke, van Kaam, Anton H., and Onland, Wes

Published
2022
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20. Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial

Author

Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L. J., Lopriore, Enrico, Onland, Wes, Vermeulen, Marijn J., van den Akker–van Marle, M. Elske, van Bodegom–Vos, Leti, de Boode, Willem P., van Kaam, Anton H., Reiss, Irwin K. M., Polglase, Graeme R., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E. M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., Hooper, Stuart B., and te Pas, Arjan B.

Published
2022
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23. Impaired lung function and associated risk factors in children born prematurely: a systematic review and meta-analysis.

Author

van Boven, Menne R., Hutten, Gerard J., Richardson, Rianne, Königs, Marsh, Leemhuis, Aleid G., Onland, Wes, Terheggen-Lagro, Suzanne W. J., Oosterlaan, Jaap, and van Kaam, Anton H.

Subjects
BRONCHOPULMONARY dysplasia, GESTATIONAL age, LUNG development, REFERENCE values, ARTIFICIAL respiration
Abstract

Background Immature lung development and respiratory morbidity place preterm-born children at high risk of long-term pulmonary sequelae. This systematic review and meta-analysis aims to quantify lung function in preterm-born children and identify risk factors for a compromised lung function. Methods We searched MEDLINE, Embase, Cochrane Library, Web of Science and Scopus for relevant studies published on preterm cohorts born since 1990. Studies comparing forced expiratory volume in 1 s (FEV1) in preterm-born children aged ≥5 years to term-born controls or normative data were included. Study quality was assessed using the Newcastle-Ottawa Scale for cohort studies. Standardised mean differences in FEV1 and secondary spirometry outcomes per study were pooled using meta-analysis. The impact of different demographic and neonatal variables on studies' FEV1 effect sizes was investigated by meta-regression analyses. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations framework. Results We identified 42 studies with unique cohorts including 4743 preterm children and 9843 controls. Median gestational age in the studies was 28.0 weeks and age at assessment ranged from 6.7 to 16.7 years. Preterm children had lower FEV1 than controls (-0.58 SD, 95% CI -0.69--0.47 SD, p<0.001) resulting in a relative risk of 2.9 (95% CI 2.4-3.4) for abnormal outcome, with high certainty of evidence. FEV1 was significantly associated with gestational age, birthweight, bronchopulmonary dysplasia and invasive mechanical ventilation in univariate meta-regression analyses (R2=36-96%). Conclusion This systematic review shows robust evidence of impaired lung function in preterm-born children with a high certainty of evidence. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Author

MS Neonatologie, Willemsen, Sten P., Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Lopriore, Enrico, Onland, Wes, de Boode, Willem P., van Kaam, Anton H., Nuytemans, Debbie H., Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., te Pas, Arjan B., Vermeulen, Marijn J., MS Neonatologie, Willemsen, Sten P., Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Lopriore, Enrico, Onland, Wes, de Boode, Willem P., van Kaam, Anton H., Nuytemans, Debbie H., Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., te Pas, Arjan B., and Vermeulen, Marijn J.

Published
2024

26. Association Between Seizures and Neurodevelopmental Outcome at Two and Five Years in Asphyxiated Newborns With Therapeutic Hypothermia

Author

MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Langeslag, Juliette F, Onland, Wes, Groenendaal, Floris, de Vries, Linda S, van Kaam, Anton H, de Haan, Timo R, PharmaCool study group, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Langeslag, Juliette F, Onland, Wes, Groenendaal, Floris, de Vries, Linda S, van Kaam, Anton H, de Haan, Timo R, and PharmaCool study group

Published
2024

27. Effect of Systemic Hydrocortisone on Brain Abnormalities and Regional Brain Volumes in Ventilator-dependent Infants Born Preterm: Substudy of the SToP-BPD Study

Author

MS Neonatologie, Brain, Child Health, Developmental Disorders, Circulatory Health, Halbmeijer, Nienke M., Onland, Wes, Dudink, Jeroen, Cools, Filip, Debeer, Anne, van Kaam, Anton H., Benders, Manon J.N.L., van der Aa, Niek E., MS Neonatologie, Brain, Child Health, Developmental Disorders, Circulatory Health, Halbmeijer, Nienke M., Onland, Wes, Dudink, Jeroen, Cools, Filip, Debeer, Anne, van Kaam, Anton H., Benders, Manon J.N.L., and van der Aa, Niek E.

Published
2024

28. Physiological-based cord clamping in very preterm infants:the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Author

Willemsen, Sten P., Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Lopriore, Enrico, Onland, Wes, de Boode, Willem P., van Kaam, Anton H., Nuytemans, Debbie H., Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., te Pas, Arjan B., Vermeulen, Marijn J., Willemsen, Sten P., Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Lopriore, Enrico, Onland, Wes, de Boode, Willem P., van Kaam, Anton H., Nuytemans, Debbie H., Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., te Pas, Arjan B., and Vermeulen, Marijn J.

Abstract

Background: Mortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC. Methods: The ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent. The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years. To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data. Discussion: The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth. Trial registration: ClinicalTrials.gov NCT03808051. Registered on 17 January 2019.

Published
2024

30. Doxapram for apnoea of prematurity and neurodevelopmental outcomes at age 5–6 years

Author

Tréluyer, Ludovic, primary, Zana-Taieb, Elodie, additional, Jarreau, Pierre-Henri, additional, Benhammou, Valérie, additional, Kuhn, Pierre, additional, Letouzey, Mathilde, additional, Marchand-Martin, Laetitia, additional, Onland, Wes, additional, Pierrat, Véronique, additional, Saade, Lauren, additional, Ancel, Pierre Yves, additional, and Torchin, Héloïse, additional

Published
2024
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32. Opportunities and Challenges of Prognostic Models for Extremely Preterm Infants

Author

de Boer, Angret, primary, van Beek, Pauline E., additional, Andriessen, Peter, additional, Groenendaal, Floris, additional, Hogeveen, Marije, additional, Meijer, Julia S., additional, Obermann-Borst, Sylvia A., additional, Onland, Wes, additional, Scheepers, Liesbeth (H. C. J.), additional, Vermeulen, Marijn J., additional, Verweij, E. J. T. (Joanne), additional, De Proost, Lien, additional, and Geurtzen, Rosa, additional

Published
2023
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33. Risk Factors for Neurodevelopmental Impairment at 2- and 5-Years Corrected Age in Preterm Infants with Established Bronchopulmonary Dysplasia

Author

Katz, Trixie A., primary, van Kaam, Anton H., additional, Mugie, Suzanne M., additional, Aarnoudse-Moens, Cornelieke S.H., additional, de Groof, Femke, additional, van Kempen, Anne A.M.W., additional, van den Heuvel, Maria E. N, additional, Vogelzang, Judith, additional, Rijpert, Maarten, additional, Schiering, Irene A., additional, Koomen-Botman, Irene, additional, Visser, Fenna, additional, Leemhuis, Aleid G., additional, and Onland, Wes, additional

Published
2023
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35. Towards a harmonized bronchopulmonary dysplasia definition: a study protocol for an international Delphi procedure

Author

Katz, Trixie A, primary, Bancalari, Eduardo, additional, Gordijn, Sanne J, additional, Higgins, Rosemary D, additional, Isayama, Tetsuya, additional, Jensen, Erik A, additional, Offringa, Martin, additional, Pillow, J Jane, additional, Shah, Prakesh S, additional, Soll, Roger F, additional, Stoecklin, Benjamin, additional, Mugie, Suzanne M, additional, van Kaam, Anton H, additional, and Onland, Wes, additional

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

Author

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

Published
2023
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43. 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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44. Opportunities and Challenges of Prognostic Models for Extremely Preterm Infants

Author

de Boer, Angret, van Beek, Pauline E., Andriessen, Peter, Groenendaal, Floris, Hogeveen, Marije, Meijer, Julia S., Obermann-Borst, Sylvia A., Onland, Wes, Scheepers, Liesbeth, Vermeulen, Marijn J., Verweij, E. J.T., De Proost, Lien, Geurtzen, Rosa, de Boer, Angret, van Beek, Pauline E., Andriessen, Peter, Groenendaal, Floris, Hogeveen, Marije, Meijer, Julia S., Obermann-Borst, Sylvia A., Onland, Wes, Scheepers, Liesbeth, Vermeulen, Marijn J., Verweij, E. J.T., De Proost, Lien, and Geurtzen, Rosa

Abstract

Predicting the short- and long-term outcomes of extremely preterm infants remains a challenge. Multivariable prognostic models might be valuable tools for clinicians, parents, and policymakers for providing accurate outcome estimates. In this perspective, we discuss the opportunities and challenges of using prognostic models in extremely preterm infants at population and individual levels. At a population level, these models could support the development of guidelines for decisions about treatment limits and may support policy processes such as benchmarking and resource allocation. At an individual level, these models may enhance prenatal counselling conversations by considering multiple variables and improving transparency about expected outcomes. Furthermore, they may improve consistency in projections shared with parents. For the development of prognostic models, we discuss important considerations such as predictor and outcome measure selection, clinical impact assessment, and generalizability. Lastly, future recommendations for developing and using prognostic models are suggested. Importantly, the purpose of a prognostic model should be clearly defined, and integrating these models into prenatal counselling requires thoughtful consideration.

Published
2023

45. 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

46. OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE):study protocol of a multicentre, retrospective cohort study

Author

van de Meent, Mette, Kleuskens, Dianne G., Ganzevoort, Wessel, Gordijn, Sanne J., Kooi, Elisabeth M.W., Onland, Wes, van Rijn, Bas B., Duvekot, Johannes J., Kornelisse, René F., Al-Nasiry, Salwan, Jellema, Reint K., Knol, H. Marieke, Manten, Gwendolyn T.R., Mulder-de Tollenaer, Susanne M., Derks, Jan B., Groenendaal, Floris, Bekker, Mireille N., Schuit, Ewoud, Lely, A. Titia, Kooiman, Judith, van de Meent, Mette, Kleuskens, Dianne G., Ganzevoort, Wessel, Gordijn, Sanne J., Kooi, Elisabeth M.W., Onland, Wes, van Rijn, Bas B., Duvekot, Johannes J., Kornelisse, René F., Al-Nasiry, Salwan, Jellema, Reint K., Knol, H. Marieke, Manten, Gwendolyn T.R., Mulder-de Tollenaer, Susanne M., Derks, Jan B., Groenendaal, Floris, Bekker, Mireille N., Schuit, Ewoud, Lely, A. Titia, and Kooiman, Judith

Abstract

Introduction Early-onset fetal growth restriction (FGR) requires timely, often preterm, delivery to prevent fetal hypoxia causing stillbirth or neurologic impairment. Antenatal corticosteroids (CCS) administration reduces neonatal morbidity and mortality following preterm birth, most effectively when administered within 1 week preceding delivery. Optimal timing of CCS administration is challenging in early-onset FGR, as the exact onset and course of fetal hypoxia are unpredictable. International guidelines do not provide a directive on this topic. In the Netherlands, two timing strategies are commonly practiced: administration of CCS when the umbilical artery shows (A) a pulsatility index above the 95th h centile and (B) absent or reversed end-diastolic velocity (a more progressed disease state). This study aims to (1) use practice variation to compare CCS timing strategies in early-onset FGR on fetal and neonatal outcomes and (2) develop a dynamic tool to predict the time interval in days until delivery, as a novel timing strategy for antenatal CCS in early-onset FGR. Methods and analysis A multicentre, retrospective cohort study will be performed including pregnancies complicated by early-onset FGR in six tertiary hospitals in the Netherlands in the period between 2012 and 2021 (estimated sample size n=1800). Main exclusion criteria are multiple pregnancies and fetal congenital or genetic abnormalities. Routinely collected data will be extracted from medical charts. Primary outcome for the comparison of the two CCS timing strategies is a composite of perinatal, neonatal and in-hospital mortality. Secondary outcomes include the COSGROVE core outcome set for FGR. A multivariable, mixed-effects model will be used to compare timing strategies on study outcomes. Primary outcome for the dynamic prediction tool is € days until birth'. Ethics and dissemination The need for ethical approval was waived by the Ethics Committee (University Medical Center Utrecht). Results

Published
2023

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

Author

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

Published
2023

48. Opportunities and Challenges of Prognostic Models for Extremely Preterm Infants

Author

MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, de Boer, Angret, van Beek, Pauline E, Andriessen, Peter, Groenendaal, Floris, Hogeveen, Marije, Meijer, Julia S, Obermann-Borst, Sylvia A, Onland, Wes, Scheepers, Liesbeth H C J, Vermeulen, Marijn J, Verweij, E J T Joanne, De Proost, Lien, Geurtzen, Rosa, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, de Boer, Angret, van Beek, Pauline E, Andriessen, Peter, Groenendaal, Floris, Hogeveen, Marije, Meijer, Julia S, Obermann-Borst, Sylvia A, Onland, Wes, Scheepers, Liesbeth H C J, Vermeulen, Marijn J, Verweij, E J T Joanne, De Proost, Lien, and Geurtzen, Rosa

Published
2023

49. Prediction Models for Bronchopulmonary Dysplasia in Preterm Infants: A Systematic Review and Meta-Analysis

Author

Epi Methoden Team 4, Cancer, JC onderzoeksprogramma Methodologie, Romijn, Michelle, Dhiman, Paula, Finken, Martijn J J, van Kaam, Anton H, Katz, Trixie A, Rotteveel, Joost, Schuit, Ewoud, Collins, Gary S, Onland, Wes, Torchin, Heloise, Epi Methoden Team 4, Cancer, JC onderzoeksprogramma Methodologie, Romijn, Michelle, Dhiman, Paula, Finken, Martijn J J, van Kaam, Anton H, Katz, Trixie A, Rotteveel, Joost, Schuit, Ewoud, Collins, Gary S, Onland, Wes, and Torchin, Heloise

Published
2023

50. OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE): study protocol of a multicentre, retrospective cohort study

Author

MS Verloskunde, Other research (not in main researchprogram), MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Circulatory Health, Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, Arts-assistenten DV&B, van de Meent, Mette, Kleuskens, Dianne G, Ganzevoort, Wessel, Gordijn, Sanne J, Kooi, Elisabeth M W, Onland, Wes, van Rijn, Bas B, Duvekot, Johannes J, Kornelisse, René F, Al-Nasiry, Salwan, Jellema, Reint K, Knol, H Marieke, Manten, Gwendolyn T R, Mulder-de Tollenaer, Susanne M, Derks, Jan B, Groenendaal, Floris, Bekker, Mireille N, Schuit, Ewoud, Lely, A Titia, Kooiman, Judith, MS Verloskunde, Other research (not in main researchprogram), MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Circulatory Health, Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, Arts-assistenten DV&B, van de Meent, Mette, Kleuskens, Dianne G, Ganzevoort, Wessel, Gordijn, Sanne J, Kooi, Elisabeth M W, Onland, Wes, van Rijn, Bas B, Duvekot, Johannes J, Kornelisse, René F, Al-Nasiry, Salwan, Jellema, Reint K, Knol, H Marieke, Manten, Gwendolyn T R, Mulder-de Tollenaer, Susanne M, Derks, Jan B, Groenendaal, Floris, Bekker, Mireille N, Schuit, Ewoud, Lely, A Titia, and Kooiman, Judith

Published
2023

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