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Title
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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
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Author
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Institution/Organisation
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SToP-BPD Study Group
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Abstract
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| 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 Results The composite outcome was available in 356 (96.0%) of 371 patients (one consent withdrawn).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 itscomponent death. There was insufficient evidence for other selected candidate effect modifiers. |
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Language
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English
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Source (journal)
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Archives of disease in childhood : fetal and neonatal edition. - London, 1988, currens
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Publication
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London
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Bmj publishing group
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2024
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ISSN
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1359-2998
[print]
1468-2052
[online]
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DOI
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10.1136/ARCHDISCHILD-2023-325558
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Volume/pages
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109
(2024)
, p. 159-165
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ISI
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001070633500001
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Pubmed ID
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37722765
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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