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Published in: Trials 1/2018

Open Access 01-12-2018 | Update

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan

Authors: Wes Onland, Maruschka P. Merkus, Debbie H. Nuytemans, Marijke C. Jansen-van der Weide, Rebecca Holman, Anton H. van Kaam, on behalf of the SToP-BPD study group

Published in: Trials | Issue 1/2018

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Abstract

Background

Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants.

Methods/design

The SToP-BPD study is a multicentre, double-blind, placebo-controlled hydrocortisone trial in preterm infants at risk for BPD. After parental informed consent is obtained, ventilator-dependent infants are randomly allocated to hydrocortisone or placebo treatment during a 22-day period. The primary outcome measure is the composite outcome of death or BPD at 36 weeks postmenstrual age. Secondary outcomes are short-term effects on pulmonary condition and long-term neurodevelopmental sequelae assessed at 2 years corrected age. Complications of treatment, other serious adverse events and suspected unexpected serious adverse reactions are reported as safety outcomes. This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data.

Trial registration

Netherlands Trial Register, NTR2768. Registered on 17 February 2011. EudraCT, 2010-023777-19. Registered on 2 November 2010.
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Metadata
Title
Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
Authors
Wes Onland
Maruschka P. Merkus
Debbie H. Nuytemans
Marijke C. Jansen-van der Weide
Rebecca Holman
Anton H. van Kaam
on behalf of the SToP-BPD study group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2505-y

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