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Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial
Sara B DeMauro1,2, Haresh Kirpalani1,2, Susan Hintz3
1Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Insights
Neonatal hydrocortisone treatment did not improve school-age outcomes for preterm infants at risk for bronchopulmonary dysplasia (BPD). Nearly three-quarters of children experienced functional impairment, regardless of treatment.
Area of Science:
- Neonatal medicine
- Pediatric pulmonology
- Clinical trials
Background:
- Bronchopulmonary dysplasia (BPD) is a common complication in premature infants, leading to long-term health issues.
- The Neonatal Research Network (NRN) previously investigated hydrocortisone for BPD prevention.
- Long-term school-age outcomes following this trial were previously unreported.
Purpose of the Study:
- To assess the impact of neonatal hydrocortisone on functional motor, cognitive, academic, and pulmonary outcomes at school age.
- To evaluate the long-term effects of hydrocortisone treatment in very preterm infants.
Main Methods:
- A prospective long-term follow-up of the NRN Hydrocortisone for BPD Trial.
- Randomized trial participants (born <30 weeks GA, mechanically ventilated) attended school-age visits (corrected age 5-7 years).
- Functional impairment defined as cognitive, motor, academic delay, or poor exercise capacity.
Main Results:
- No significant difference in functional impairment rates between hydrocortisone and placebo groups (71.3% vs. 73.3%).
- Individual components of functional impairment also showed no differences between groups.
- Motor delay (60.4%) and poor functional exercise capacity (36.2%) were the most common impairments.
Conclusions:
- Neonatal hydrocortisone treatment did not affect school-age functional outcomes in preterm infants at high risk for BPD.
- A high prevalence of functional impairment was observed in this cohort at school age.
- Findings suggest hydrocortisone is not beneficial for long-term functional outcomes in this population.
Importance:
Bronchopulmonary dysplasia (BPD) is the most common in-hospital morbidity of prematurity, associated with significant long-term medical and neurodevelopmental sequelae and health resource utilization. The Neonatal Research Network (NRN) Hydrocortisone for BPD Trial evaluated the efficacy and safety of hydrocortisone to prevent BPD in high-risk very preterm infants; the impact of hydrocortisone on school-age outcomes in this trial cohort is previously unreported.
Objective:
To evaluate the impact of neonatal hydrocortisone treatment on early school-age functional motor, cognitive, academic, and pulmonary outcomes among children who participated in the Hydrocortisone for BPD Trial.
Design, Setting, And Participants:
This prospective long-term cohort study is a follow-up of a randomized clinical trial, the Hydrocortisone for BPD Trial, conducted at 19 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development NRN. Participants, enrolled from August 2011 to February 2018, included intubated infants who had been born before 30 weeks' gestational age and had been mechanically ventilated for at least 7 days by postnatal day 14 to 28. They were eligible for a single, in-person, early school-age visit between corrected age 5 years 0 months and 7 years 11 months, conducted from September 2017 to July 2024. Data analysis was performed from July 2024 to September 2025.
Intervention:
Participants were randomized to a 10-day tapering course of hydrocortisone or placebo beginning at 14 to 28 postnatal days.
Main Outcomes And Measures:
Early school-age study visits were performed by certified, masked assessors. The primary outcome of functional impairment was defined as any of the following: cognitive delay, motor delay, academic delay, or poor functional exercise capacity.
Results:
The primary outcome was available for 545 of 674 eligible children (80.9%), including 272 children in the hydrocortisone group (152 [55.9%] female; mean [SD] gestational age, 24.9 [1.5] weeks; mean [SD] age at visit, 5.3 [0.6] years) and 273 in the placebo group (108 [39.6%] female; mean [SD] gestational age, 24.8 [1.5] weeks; mean [SD] age at visit, 5.4 [0.6] years). There was no difference in the rate of functional impairment between the hydrocortisone group (194 of 272 children [71.3%]) and the placebo group (200 of 273 children [73.3%]) (adjusted relative risk, 0.99; 95% CI, 0.89-1.10), nor were there differences in the rates of the individual components. Motor delay was the most common impairment (308 of 510 children [60.4%]), followed by poor functional exercise capacity (175 of 484 children [36.2%]).
Conclusions And Relevance:
In this study, neonatal hydrocortisone treatment of preterm infants with high risk for BPD did not impact functional impairment or its components; nearly three-quarters of the children demonstrated functional impairment at school age.
Trial Registration:
ClinicalTrials.gov Identifier: NCT01353313.
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