Identifying effect modifiers of systemic hydrocortisone treatment initiated 7-14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial.

Autor:	Halbmeijer NM; Neonatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.; Research Institute, Amsterdam Reproduction and Development, Amsterdam, The Netherlands., Sonnaert M; Neonatology, Universitair Ziekenhuis Brussel, Brussels, Belgium., Swarte RM; Neonatology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands., Koopman-Esseboom C; Neonatology, University Medical Centre Utrecht/Wilhelmina Children's Hospital, Utrecht, The Netherlands., van Stuijvenberg M; Neonatology, University Medical Centre Groningen, Beatrix Children's Hospital, Groningen, The Netherlands., Mulder-de Tollenaer S; Neonatology, Isala Medical Centre, Zwolle, The Netherlands., Tan RNGB; Neonatology, Leiden University Medical Center, Leiden, The Netherlands., Mohns T; Neonatology, Maxima Medical Centre, Women Mother and Child Centre, Veldhoven, The Netherlands., Bruneel E; Neonatology, Ziekenhuis Oost-Limburg, Genk, Belgium., Steiner K; Neonatology, Radboudumc Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, The Netherlands., Kramer BW; School of Women's and Infants' Health, University of Western Australia, Crawley, Western Australia, Australia.; Research & Development, Neuroplast BV, Maastricht, The Netherlands., Debeer A; Neonatology, University Hospitals Leuven, Leuven, Belgium., van Weissenbruch MM; Research Institute, Amsterdam Reproduction and Development, Amsterdam, The Netherlands.; Neonatology, Amsterdam UMC Location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands., Marechal Y; Neonatology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium., Blom H; Neonatology, Universitair Ziekenhuis Antwerpen, Edegem, Belgium., Plaskie K; Neonatology, St Augustinus ziekenhuis, Antwerp, Belgium., Offringa M; Neonatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.; Neonatology and Child Health Evaluative Sciences, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada., Merkus MP; Epidemiology and Data Science, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands., Onland W; Neonatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.; Research Institute, Amsterdam Reproduction and Development, Amsterdam, The Netherlands., Leemhuis AG; Neonatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.; Research Institute, Amsterdam Reproduction and Development, Amsterdam, The Netherlands., van Kaam AH; Neonatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands a.h.vankaam@amsterdamumc.nl.; Research Institute, Amsterdam Reproduction and Development, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	Archives of disease in childhood. Fetal and neonatal edition [Arch Dis Child Fetal Neonatal Ed] 2024 Feb 19; Vol. 109 (2), pp. 159-165. Date of Electronic Publication: 2024 Feb 19.
DOI:	10.1136/archdischild-2023-325558
Abstrakt:	Objective: To explore clinical effect modifiers of systemic hydrocortisone in ventilated very preterm infants for survival and neurodevelopmental outcome at 2 years' corrected age (CA). Design: Secondary analysis of a randomised placebo-controlled trial. Setting: Dutch and Belgian neonatal intensive care units. Patients: Infants born <30 weeks' gestational age (GA), ventilator-dependent in the second week of postnatal life. Intervention: Infants were randomly assigned to systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190). Main Outcome Measures: The composite of death or neurodevelopmental impairment (NDI) at 2 years' CA and its components. Candidate effect modifiers (GA, small for GA, respiratory index, sex, multiple births, risk of moderate/severe bronchopulmonary dysplasia or death) were analysed using regression models with interaction terms and subpopulation treatment effect pattern plots. Results: The composite outcome was available in 356 (96.0%) of 371 patients (one consent withdrawn). For this outcome, treatment effect heterogeneity was seen across GA subgroups (<27 weeks: hydrocortisone (n=141) vs placebo (n=156), 54.6% vs 66.2%; OR 0.61 (95% CI 0.38 to 0.98); ≥27 weeks: hydrocortisone (n=30) vs placebo (n=31), 66.7% vs 45.2%; OR 2.43 (95% CI 0.86 to 6.85); p=0.02 for interaction). This effect was also found for the component death (<27 weeks: 20.1% vs 32.1%; OR 0.53 (95% CI 0.32 to 0.90); ≥27 weeks: 28.1% vs 16.1%; OR 2.04 (95% CI 0.60 to 6.95); p=0.049 for interaction) but not for the component NDI. No differential treatment effects were observed across other subgroups. Conclusion: This secondary analysis suggests that in infants <27 weeks' GA, systemic hydrocortisone may improve the outcome death or NDI, mainly driven by its component death. There was insufficient evidence for other selected candidate effect modifiers. Competing Interests: Competing interests: AHvK reports grants from the Netherlands Organization for Health Research and Development (ZonMW) during the conduct of the study. No other disclosures were reported. (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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