TY - JOUR
T1 - Effect of Systemic Hydrocortisone in Ventilated Infants Born Preterm
T2 - Mortality and 5.5-Year Neurodevelopmental Outcomes of a Randomized Clinical Trial
AU - SToP-BPD Trial Collaborators
AU - de Baat, Tessa
AU - van de Loo, Moniek
AU - Aarnoudse-Moens, Cornelieke S H
AU - Halbmeijer, Nienke M
AU - Onland, Wes
AU - van Kaam, Anton H
AU - Koopman, Corine
AU - Swarte, Renate M C
AU - Mulder-de Tollenaer, Susanne M
AU - van Stuijvenberg, Margriet
AU - Tan, Ratna N G B
AU - de Kort, Ellen
AU - Bruneel, Els
AU - Cools, Filip
AU - Steiner, Katerina
AU - Debeer, Anne
AU - Van Mechelen, Karen
AU - Blom, Henry
AU - Maréchal, Yoann
AU - Plaskie, Katleen
AU - Leemhuis, Aleid G
N1 - Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.
PY - 2025/12/13
Y1 - 2025/12/13
N2 - 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.
AB - 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.
U2 - 10.1016/j.jpeds.2025.114954
DO - 10.1016/j.jpeds.2025.114954
M3 - Article
C2 - 41391545
SN - 0022-3476
VL - 290
SP - 114954
JO - Journal of pediatrics
JF - Journal of pediatrics
ER -