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

BMC Pediatrics

Study Protocol

Eric Cavatorta¹  Anne P De Jaegere²  Anton H van Kaam²  Wes Onland²  Martin Offringa³  Andre A Kroon⁴  Henrica L van Straaten⁵  Arjan B te Pas⁶  Boris W Kramer⁷  Thilo Mohns⁸  Arno F van Heijst⁹  Henry Blom^1,10  Filip Cools^1,11  Anne Debeer^1,12  Peter H Dijk^1,13  Mirjam M van Weissenbruch^1,14  Karin Rademaker^1,15  Claire Theyskens^1,16 

[1] Department of Neonatology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium;Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands;Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands;Department of Paediatric Clinical Epidemiology, Emma Children's Hospital, Academic Medical Center, University of Amsterdam, The Netherlands;Department of Neonatology, ErasmusMC-Sophia, Rotterdam, The Netherlands;Department of Neonatology, Isala Clinics, Zwolle, The Netherlands;Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands;Department of Neonatology, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Neonatology, Maxima Medical Center Veldhoven, The Netherlands;Department of Neonatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands;Department of Neonatology, Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium;Department of Neonatology, Universitair Ziekenhuis Brussel, Brussel, Belgium;Department of Neonatology, Universitair Ziekenhuis Leuven, Leuven, Belgium;Department of Neonatology, University Medical Center Groningen, Groningen, The Netherlands;Department of Neonatology, VU University Medical Center, Amsterdam, The Netherlands;Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands;Department of Neonatology, Ziekenhuis Oost-Limburg, Genk, Belgium;

关键词: Hydrocortisone;    Preterm Infant;    Congenital Diaphragmatic Hernia;    Bronchopulmonary Dysplasia;    Data Monitoring Committee;   

DOI  :  10.1186/1471-2431-11-102

 received in 2011-09-16, accepted in 2011-11-09,  发布年份 2011

来源: Springer

【 摘 要 】

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.Trial registration numberNetherlands Trial Register (NTR): NTR2768

【 授权许可】

Unknown   
© Onland et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.