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Effect of Systemic Hydrocortisone in Ventilated Infants Born Preterm: Mortality and 5.5-Year Neurodevelopmental
T de Baat1, M van de Loo1, C S H Aarnoudse-Moens2
1Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, The Netherlands; Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Insights
Hydrocortisone treatment in preterm infants did not improve neurodevelopmental outcomes or reduce mortality by age 5.5. This study found no significant differences in cognitive, motor, or neurosensory functions between hydrocortisone and placebo groups.
Area of Science:
- Neonatal Medicine
- Pediatric Neurology
- Developmental Pediatrics
Background:
- Bronchopulmonary dysplasia (BPD) is a significant complication in preterm infants requiring mechanical ventilation.
- Early administration of systemic hydrocortisone (HC) has been explored to prevent BPD and improve outcomes.
- The Systemic hydrocortisone (HC) To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) study investigated HC's efficacy.
Purpose of the Study:
- To evaluate neurodevelopmental outcomes at 5.5 years corrected age in preterm infants from the SToP-BPD study.
- To compare neurodevelopmental outcomes and mortality between HC treatment and placebo in mechanically ventilated preterm infants.
- To assess the impact of HC initiated between 7 and 14 days after birth.
Main Methods:
- Longitudinal follow-up data collected at 5.5 years corrected age.
- Assessment of cognitive, motor, neurosensory functioning, behavior, schooling, and general health.
- Primary outcome: death or moderate-severe neurodevelopmental impairment (NDI), defined by deficits in cognition, motor, vision, or hearing.
Main Results:
- NDI assessed in 77% of surviving children; follow-up participants had more educated/non-smoking parents and better prior outcomes.
- No significant difference in the primary outcome (death or moderate-severe NDI) between HC and placebo groups (OR 0.75; 95% CI 0.49-1.14; P = .18).
- All separate developmental outcomes, including cognitive, motor, and neurosensory assessments, were comparable between treatment arms.
Conclusions:
- Systemic hydrocortisone treatment initiated between 7 and 14 days in preterm infants at risk for BPD did not impact death or moderate-severe NDI at 5.5 years corrected age.
- HC treatment did not significantly alter any individual developmental outcome measures at the 5.5-year follow-up.
- These findings suggest that early HC administration in this vulnerable preterm population does not confer long-term neurodevelopmental benefits.
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.
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