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Randomized Controlled Trial
. 2023 Jan;108(1):20-25.
doi: 10.1136/archdischild-2022-323882. Epub 2022 May 9.

Short-term pulmonary and systemic effects of hydrocortisone initiated 7-14 days after birth in ventilated very preterm infants: a secondary analysis of a randomised controlled trial

Nienke M Halbmeijer  1   2 , Wes Onland  1   2 , Filip Cools  3 , Andre Kroon  4 , Marja van der Heide-Jalving  5 , Peter Dijk  6 , Henrica L M van Straaten  5 , Arjan B Te Pas  7 , Thilo Mohns  8 , Els Bruneel  9 , Arno F J van Heijst  10 , Boris Kramer  11 , Anne Debeer  12 , Inge A Zonnenberg  13 , Yoann Marechal  14 , Henry Blom  15 , Katleen Plaskie  16 , Maruschka P Merkus  17 , Martin Offringa  18 , Anton H van Kaam  19   2 ; SToP-BPD Study Group; STOP-BPD Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Short-term pulmonary and systemic effects of hydrocortisone initiated 7-14 days after birth in ventilated very preterm infants: a secondary analysis of a randomised controlled trial

Nienke M Halbmeijer et al. Arch Dis Child Fetal Neonatal Ed. 2023 Jan.

Abstract

Objective: Observational studies in preterm infants suggest that systemic hydrocortisone improves pulmonary condition but may also lead to systemic adverse effects. We report the short-term pulmonary and systemic effects of hydrocortisone initiated in the second week.

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: Data on extubation, ventilator settings, glucose levels, and blood pressure were recorded daily and analysed during the first 7 days of treatment using linear mixed-effects models.

Results: Infants in the hydrocortisone group (24.3%) failed extubation less often compared with placebo (38.6%, crude risk difference: -14.3% (95% CI: -23.4% to -4.8%)). The estimated difference in daily rate of change between hydrocortisone and placebo was -0.42 cmH2O (95% CI: -0.48 to -0.36) for mean airway pressure, -0.02 (95% CI: -0.02 to -0.01) for fraction of inspired oxygen, -0.37 (95% CI: -0.44 to -0.30) for respiratory index, 0.14 mmol/L (95% CI: 0.08 to 0.21) for blood glucose levels and 0.83 mm Hg (95% CI: 0.58 to 1.09) for mean blood pressure.

Conclusions: Systemic hydrocortisone initiated between 7 and 14 days after birth in ventilated preterm infants improves pulmonary condition, thereby facilitating weaning and extubation from invasive ventilation. The effects of hydrocortisone on blood glucose levels and blood pressure were mild and of limited clinical relevance.

Trial registration number: Netherlands Trial Register (NTR2768; https://www.trialregister.nl/trial/2640) and European Union Clinical Trials Register (EudraCT, 2010-023777-19).

Keywords: Neonatology; Respiratory Medicine.

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Conflict of interest statement

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.

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