Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial

The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis.This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants.Netherlands Trial Register (NTR): NTR2768Bronchopulmonary dysplasia (BPD) is the most common complication of premature birth, with a reported incidence of 8% to 35% [1,2]. BPD is characterized by chronic respiratory distress, the need for prolonged respiratory support, an increased risk of recurrent pulmonary infections leading to hospital readmissions during the first years of life [3], and life-long alterations in lung function [4-6]. BPD is also considered an important risk factor for adverse neurodevelopmental outcome after premature birth [7-11]. These long-term consequences of BPD place a heavy burden on societal and health care costs [12-15].Pulmonary inflammation has been identified as an important risk factor in the development of BPD, providing the rationale for treating patients at risk for BPD with glucocorticoids, a group of drugs well known for its strong anti-inflammatory effect [16-18]. Randomized controlled trials (RCTs) comparing dexamethasone to placebo in ventilated preterm infan