Effect of Systemic Hydrocortisone in Ventilated Infants Born Preterm: Mortality and 5.5-Year Neurodevelopmental Outcomes of a Randomized Clinical Trial
Year: 2025
Type: article
Abstract: OBJECTIVE: To examine neurodevelopmental outcomes at 5.5 years of corrected age in children included in the Systemic hydrocortisone (HC) To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) study, and to investigate the neurodevelopmental outcomes and mortality with HC treatment started between 7 and 14 days after birth compared with placebo in infants born preterm who required mechanical ventilation. STUDY DESIGN: Data at 5.5 years of corrected age on cognitive, motor and neurosensory functioning, behavior, schooling, and general health outcomes were derived from regular follow-up visits. The primary outcome was death or moderate-severe neurodevelopmental impairment (NDI, complete case analysis), with NDI defined as a disability in at least 1 of the domains of cognition, motor development, vision, or hearing. Other outcomes included neurologic and behavioral assessments as well as parent reports of service use and school function. RESULTS: NDI was assessed in 213 of the 277 (77%) surviving children. Children attending follow-up were more likely to have highly educated or nonsmoking parents and had better neurodevelopmental outcomes at 2 years of corrected age than nonattending children. Baseline characteristics of assessed children were comparable between treatment arms. No significant difference was found on the primary outcome (OR 0.75; 95% CI 0.49-1.14; P = .18). All developmental outcomes were comparable between the HC and placebo group. CONCLUSIONS: Treatment with HC started between 7 and 14 days after birth in infants born preterm at risk of BPD did not affect death or moderate-severe NDI nor any of the separate developmental outcome measures at 5.5 years of corrected age. TRIAL REGISTRATION: 2010-023777-19; https://www.clinicaltrialsregister.eu.
Source: The Journal of Pediatrics
Authors: Tessa de Baat, Moniek van de Loo, Cornelieke S.H. Aarnoudse-Moens, Nienke M. Halbmeijer, Wes Onland, Anton H. van Kaam, Corine Koopman, Renate M.C. Swarte, Susanne M. Mulder-de Tollenaer, Margriet van Stuijvenberg, Ratna N.G.B. Tan, Ellen de Kort, Els Bruneel, Filip Cools, Katerina Steiner, Anne Debeer, Karen Van Mechelen, Henry Blom, Yoann Maréchal, Katleen Plaskie, Aleid G. Leemhuis, A.P. van der Kaa, E.G. Eltringham, H.L.M. van Straaten, P.H. Dijk, A. van Steenis, M. Rijken, M.R. van Hoestenberghe, E. Cloet, A.J.W.M. Janssen, A.M.A. Damhuis, A. Eerdekens, S. Haverbeke, T. Lebon, A. Rassart, E. Cavatorta
Institutions: Emma Kinderziekenhuis, Amsterdam University Medical Centers, Amsterdam Reproduction Development, University of Amsterdam, Amsterdam UMC Location University of Amsterdam, University Medical Center Utrecht, Erasmus MC, Erasmus MC - Sophia Children’s Hospital, Isala, University Medical Center Groningen, University of Groningen, Beatrix Kinderziekenhuis, Leiden University Medical Center, Máxima Medisch Centrum, Ziekenhuis Oost-Limburg, Universitair Ziekenhuis Brussel, Radboud University Nijmegen, Radboud University Medical Center, Amalia Kinderziekenhuis, Universitair Ziekenhuis Leuven, Maastricht University Medical Centre, Maastricht University, Antwerp University Hospital, GZA Ziekenhuizen Campus Sint-Augustinus
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,570
Funders: Amsterdam University Medical Centers, Universiteit Leiden, Rijksuniversiteit Groningen, Universiteit van Amsterdam, Radboud Universiteit, Vrije Universiteit Brussel, Leids Universitair Medisch Centrum, Universitair Medisch Centrum Groningen, Radboud Universitair Medisch Centrum, Erasmus MC Sophia Kinderziekenhuis
OpenAlex ID: W4417290023