• Wes Onland, Martin Offringa, Filip Cools, Anne P De Jaegere, Karin Rademaker, Henry Blom, Eric Cavatorta, Anne Debeer, Peter H Dijk, Arno F van Heijst, Boris W Kramer, Andre A Kroon, Thilo Mohns, Henrica L van Straaten, Arjan B te Pas, Claire Theyskens, Mirjam M van Weissenbruch, and Anton H van Kaam.
• Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
• Bmc Pediatr. 2011 Jan 1;11:102.

BackgroundRandomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants.Methods/DesignThe 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.DiscussionThis 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.

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