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Open Access Highly Accessed Study protocol

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

Wes Onland1, Martin Offringa12, Filip Cools3, Anne P De Jaegere1, Karin Rademaker4, Henry Blom5, Eric Cavatorta6, Anne Debeer7, Peter H Dijk8, Arno F van Heijst9, Boris W Kramer10, Andre A Kroon11, Thilo Mohns12, Henrica L van Straaten13, Arjan B te Pas14, Claire Theyskens15, Mirjam M van Weissenbruch16 and Anton H van Kaam1*

Author Affiliations

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

2 Department of Paediatric Clinical Epidemiology, Emma Children's Hospital, Academic Medical Center, University of Amsterdam, the Netherlands

3 Department of Neonatology, Universitair Ziekenhuis Brussel, Brussel, Belgium

4 Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands

5 Department of Neonatology, Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium

6 Department of Neonatology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium

7 Department of Neonatology, Universitair Ziekenhuis Leuven, Leuven, Belgium

8 Department of Neonatology, University Medical Center Groningen, Groningen, The Netherlands

9 Department of Neonatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

10 Department of Neonatology, Maastricht University Medical Center, Maastricht, The Netherlands

11 Department of Neonatology, ErasmusMC-Sophia, Rotterdam, The Netherlands

12 Department of Neonatology, Maxima Medical Center Veldhoven, the Netherlands

13 Department of Neonatology, Isala Clinics, Zwolle, The Netherlands

14 Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands

15 Department of Neonatology, Ziekenhuis Oost-Limburg, Genk, Belgium

16 Department of Neonatology, VU University Medical Center, Amsterdam, The Netherlands

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BMC Pediatrics 2011, 11:102  doi:10.1186/1471-2431-11-102

Published: 9 November 2011

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 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.

Discussion

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.

Trial registration number

Netherlands Trial Register (NTR): NTR2768