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

Nienke Marjolein Halbmeijer, Wes Onland, Filip Cools, Renate M. Swarte, Marja Van Der Heide-Jalving, Peter Dijk, Susanne Mulder-De Tollenaer, Ratna N.G.B. Tan, Thilo Mohns, Els Bruneel, Arno F.J. Van Heijst, Boris Kramer, Anne Debeer, Mirjam M. Van Weissenbruch, Yoann Marechal, Henry Blom, Katleen Plaskie, Martin Offringa, Aleid G. Van Wassenaer-Leemhuis, Anton H. Van KaamCornelieke S.H. Aarnoudse-Moens*

*Bijbehorende auteur voor dit werk

    OnderzoeksoutputAcademicpeer review

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    Samenvatting

    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.

    Originele taal-2English
    Pagina's (van-tot)373-379
    Aantal pagina's7
    TijdschriftArchives of Disease in Childhood: Fetal and Neonatal Edition
    Volume108
    Nummer van het tijdschrift4
    DOI's
    StatusPublished - jul.-2023

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