TY - JOUR
T1 - Short-term pulmonary and systemic effects of hydrocortisone initiated 7-14 days after birth in ventilated very preterm infants
T2 - a secondary analysis of a randomised controlled trial
AU - SToP-BPD Study Group
AU - Halbmeijer, Nienke M
AU - Onland, Wes
AU - Cools, Filip
AU - Kroon, Andre
AU - van der Heide-Jalving, Marja
AU - Dijk, Peter
AU - van Straaten, Henrica L M
AU - Te Pas, Arjan B
AU - Mohns, Thilo
AU - Bruneel, Els
AU - van Heijst, Arno F J
AU - Kramer, Boris
AU - Debeer, Anne
AU - Zonnenberg, Inge A
AU - Marechal, Yoann
AU - Blom, Henry
AU - Plaskie, Katleen
AU - Merkus, Maruschka P
AU - Offringa, Martin
AU - van Kaam, Anton H
N1 - Funding Information: This trial was funded by a project grant from The Netherlands Organization for Health Research and Development ZonMW Priority Medicines for Children (no. 11-32010-02). Publisher Copyright: ©
PY - 2022/5/9
Y1 - 2022/5/9
N2 - 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 cmH 2 O (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).
AB - 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 cmH 2 O (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).
KW - Neonatology
KW - Respiratory Medicine
UR - http://www.scopus.com/inward/record.url?scp=85144416239&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/archdischild-2022-323882
DO - https://doi.org/10.1136/archdischild-2022-323882
M3 - Article
C2 - 35534184
SN - 1359-2998
VL - 108
SP - F20-F25
JO - Archives of Disease in Childhood-Fetal and Neonatal Edition
JF - Archives of Disease in Childhood-Fetal and Neonatal Edition
IS - 1
ER -