TY - JOUR
T1 - Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age
T2 - follow-up of a randomised clinical trial
AU - Halbmeijer, Nienke Marjolein
AU - Onland, Wes
AU - Cools, Filip
AU - Swarte, Renate M.
AU - van der Heide-Jalving, Marja
AU - Dijk, Peter
AU - Mulder-de Tollenaer, Susanne
AU - Tan, Ratna N. G. B.
AU - Mohns, Thilo
AU - Bruneel, Els
AU - van Heijst, Arno F. J.
AU - Kramer, Boris
AU - Debeer, Anne
AU - van Weissenbruch, Mirjam M.
AU - Marechal, Yoann
AU - Blom, Henry
AU - Plaskie, Katleen
AU - Offringa, Martin
AU - van Wassenaer-Leemhuis, Aleid G.
AU - van Kaam, Anton H.
AU - SToP-BPD Study Group
AU - Aarnoudse-Moens, Cornelieke S. H.
N1 - Funding Information: This trial was funded by a project grant from the Netherlands Organisation for Health Research and Development (ZonMw) Priority Medicines for Children (11-32010-02). Publisher Copyright: © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/7/1
Y1 - 2023/7/1
N2 - 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.
AB - 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.
KW - Child Development
KW - Neonatology
UR - http://www.scopus.com/inward/record.url?scp=85163921060&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/archdischild-2022-324179
DO - https://doi.org/10.1136/archdischild-2022-324179
M3 - Article
C2 - 36593110
SN - 1359-2998
VL - 108
SP - 373
EP - 379
JO - Archives of disease in childhood. Fetal and neonatal edition
JF - Archives of disease in childhood. Fetal and neonatal edition
IS - 4
ER -