Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age: follow-up of a randomised clinical trial

Halbmeijer, N.M.; Onland, W.; Cools, F.; Swarte, R.M.; Heide-Jalving, M. van der; Dijk, P.; Mulder-de Tollenaer, S.; Tan, R.N.G.B.; Mohns, T.; Bruneel, E.; Heijst, A.F.J. van; Kramer, B.; Debeer, A.; Weissenbruch, M.M. van; Marechal, Y.; Blom, H.; Plaskie, K.; Offringa, M.; Wassenaer-Leemhuis, A.G. van; Kaam, A.H. van; Aarnoudse-Moens, C.S.H.; STOP-BPD Study Grp

doi:doi:10.1136/archdischild-2022-324179

ObjectiveTo 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). DesignRandomised placebo-controlled trial. SettingDutch and Belgian neonatal intensive care units. PatientsInfants born <30 weeks' gestation and/or birth weight <1250 g, and ventilator dependent in the second week of life. InterventionInfants 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 measuresParent-reported behavioural outcomes at 2 years' CA assessed with the Child Behavior Checklist (CBCL 11/2-5). ResultsParents 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,...Show moreObjectiveTo 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). DesignRandomised placebo-controlled trial. SettingDutch and Belgian neonatal intensive care units. PatientsInfants born <30 weeks' gestation and/or birth weight <1250 g, and ventilator dependent in the second week of life. InterventionInfants 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 measuresParent-reported behavioural outcomes at 2 years' CA assessed with the Child Behavior Checklist (CBCL 11/2-5). ResultsParents 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). ConclusionThis 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.Show less

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Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age: follow-up of a randomised clinical trial