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

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 advers...

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Autores principales: Onland, Wes, Merkus, Maruschka P., Nuytemans, Debbie H., Jansen-van der Weide, Marijke C., Holman, Rebecca, van Kaam, Anton H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5845134/
https://www.ncbi.nlm.nih.gov/pubmed/29523175
http://dx.doi.org/10.1186/s13063-018-2505-y
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author Onland, Wes
Merkus, Maruschka P.
Nuytemans, Debbie H.
Jansen-van der Weide, Marijke C.
Holman, Rebecca
van Kaam, Anton H.
author_facet Onland, Wes
Merkus, Maruschka P.
Nuytemans, Debbie H.
Jansen-van der Weide, Marijke C.
Holman, Rebecca
van Kaam, Anton H.
author_sort Onland, Wes
collection PubMed
description 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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spelling pubmed-58451342018-03-14 Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan Onland, Wes Merkus, Maruschka P. Nuytemans, Debbie H. Jansen-van der Weide, Marijke C. Holman, Rebecca van Kaam, Anton H. Trials Update 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. BioMed Central 2018-03-09 /pmc/articles/PMC5845134/ /pubmed/29523175 http://dx.doi.org/10.1186/s13063-018-2505-y Text en © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Update
Onland, Wes
Merkus, Maruschka P.
Nuytemans, Debbie H.
Jansen-van der Weide, Marijke C.
Holman, Rebecca
van Kaam, Anton H.
Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title_full Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title_fullStr Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title_full_unstemmed Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title_short Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
title_sort systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the stop-bpd study): statistical analysis plan
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5845134/
https://www.ncbi.nlm.nih.gov/pubmed/29523175
http://dx.doi.org/10.1186/s13063-018-2505-y
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