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

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

SUBMITTER: Onland W 

PROVIDER: S-EPMC5845134 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature