systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the stop-bpd study); a multicenter randomized placebo controlled trial系统性氢化可的松,防止在早产儿支气管肺的发育不良(stop-bpd研究);.pdf

Onland et al. BMC Pediatrics 2011, 11:102 /1471-2431/11/102 STUDY PROTOCOL Open Access Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial 1 1,2 3 1 4 5 6 Wes Onland , Martin Offringa , Filip Cools , Anne P De Jaegere , Karin Rademaker , Henry Blom , Eric Cavatorta , 7 8 9 10 11 12 Anne Debeer , Peter H Dijk , Arno F van Heijst , Boris W Kramer , Andre A Kroon , Thilo Mohns , Henrica L van Straaten13, Arjan B te Pas14, Claire Theyskens15, Mirjam M van Weissenbruch16 and Anton H van Kaam1* Abstract Background: Randomized 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/Design: 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 out