Article Text
Abstract
Objective To report the parent-reported behavioural outcomes of infants included in the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants study at 2 years’ corrected age (CA).
Design Randomised placebo-controlled trial.
Setting Dutch and Belgian neonatal intensive care units.
Patients Infants born <30 weeks’ gestation and/or birth weight <1250 g, and ventilator dependent in the second week of life.
Intervention Infants were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).
Main outcome measures Parent-reported behavioural outcomes at 2 years’ CA assessed with the Child Behavior Checklist (CBCL 1½−5).
Results Parents completed the CBCL of 183 (70% (183/262)) infants (hydrocortisone group, n=96; placebo group, n=87). Multiple imputation was used to account for missing data. Infants with critically elevated T-scores (>55) were found in 22.9%, 19.1% and 29.4% of infants for total, internalising and externalising problems, respectively; these scores were not significantly different between groups (mean difference −1.52 (95% CI −4.00 to 0.96), −2.40 (95% CI −4.99 to 0.20) and −0.81 (95% CI −3.40 to 1.77), respectively). In the subscales, we found a significantly lower T-score for anxiety problems in the hydrocortisone group (mean difference −1.26, 95% CI −2.41 to –0.12).
Conclusion This study found high rates of behaviour problems at 2 years’ CA following very preterm birth, but these problems were not associated with hydrocortisone treatment initiated between 7 and 14 days after birth in ventilated preterm infants.
Trial registration number NTR2768; EudraCT 2010-023777-19.
- Neonatology
- Child Development
Data availability statement
Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocol, the statistical analysis plan and the analytic code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to CSHA-M, email: c.aarnoudse-moens@amsterdamumc.nl.