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Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study); a multicenter

Wes Onland1, Martin Offringa, Filip Cools

  • 1Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.

BMC Pediatrics
|November 11, 2011
PubMed

Insights

This study investigates hydrocortisone to prevent death or bronchopulmonary dysplasia (BPD) in preterm infants. It compares hydrocortisone to placebo in ventilated infants, assessing safety and neurodevelopmental outcomes.

Area of Science:

  • Neonatal Medicine
  • Pediatric Pulmonology
  • Clinical Trials

Background:

  • Dexamethasone reduces death or bronchopulmonary dysplasia (BPD) in preterm infants but carries neurodevelopmental risks.
  • Hydrocortisone is a potential alternative for treating ventilated preterm infants.
  • No randomized controlled trials have evaluated hydrocortisone for this indication after the first week of life.

Purpose of the Study:

  • To determine the efficacy and safety of postnatal hydrocortisone versus placebo in reducing mortality or BPD.
  • To assess short-term pulmonary effects and adverse events during hospitalization.
  • To evaluate long-term neurodevelopmental sequelae at 2 years corrected gestational age.

Main Methods:

  • Randomized, double-blind, placebo-controlled, multicenter trial (SToP-BPD).
  • 400 very low birth weight infants (<30 weeks GA / <1250g BW), ventilator-dependent at 7-14 days.
  • Hydrocortisone (72.5 mg/kg) or placebo over 22 days; intention-to-treat analysis.

Main Results:

  • Primary outcome: combined mortality or BPD at 36 weeks postmenstrual age.
  • Secondary outcomes: pulmonary status, adverse events, neurodevelopmental assessment at 2 years corrected age.
  • Data analysis based on intention-to-treat principles.

Conclusions:

  • The trial will provide crucial data on hydrocortisone's efficacy and safety profile.
  • Findings will inform treatment guidelines for ventilator-dependent preterm infants.
  • This study addresses a significant gap in evidence regarding early postnatal corticosteroid therapy.
Abstract

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