Abstract
BackgroundBronchopulmonary 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/designThe 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 registrationNetherlands Trial Register, NTR2768. Registered on 17 February 2011. EudraCT, 2010-023777-19. Registered on 2 November 2010.
Highlights
Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences
Pulmonary inflammation has been identified as an important risk factor in the development of BPD, providing the rationale for treating patients at risk for BPD with glucocorticoids, a group of drugs well known for their strong anti-inflammatory effect [4]
Randomised controlled trials (RCTs) comparing dexamethasone with placebo in ventilated preterm infants at risk for BPD have shown that dexamethasone reduces the
Summary
Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth [1–3]. Randomised controlled trials (RCTs) comparing dexamethasone with placebo in ventilated preterm infants at risk for BPD have shown that dexamethasone reduces the. The Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) study is the first multicentre, placebo-controlled, double-blind RCT investigating the efficacy and safety of systemic HC initiated between 7 and 14 days after birth in mechanically. Onland et al Trials (2018) 19:178 ventilated preterm infants. The study protocol was published previously [9]. This paper describes the final statistical analysis plan (SAP) in detail. This SAP was written and submitted without knowledge of the unblinded data
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