The Journal of pediatrics · 2025
Effect of Systemic Hydrocortisone in Ventilated Infants Born Preterm: Mortality and 5.5-Year Neurodevelopmental Outcomes of a Randomized Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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de Baat Tessa, van de Loo Moniek, Aarnoudse-Moens Cornelieke S H, Halbmeijer Nienke M, Onland Wes, van Kaam Anton H, Koopman Corine, Swarte Renate M C, Mulder-de Tollenaer Susanne M, van Stuijvenberg Margriet, Tan Ratna N G B, de Kort Ellen, Bruneel Els, Cools Filip, Steiner Katerina, Debeer Anne, Van Mechelen Karen, Blom Henry, Maréchal Yoann, Plaskie Katleen, Leemhuis Aleid G, SToP-BPD Trial Collaborators
Аннотация
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.
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.