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

• Published in: Current controlled trials in cardiovascular medicine 2018-03, Vol.19 (1), p.178-178, Article 178
• Main Authors: Onland, Wes, Merkus, Maruschka P, Nuytemans, Debbie H, Jansen-van der Weide, Marijke C, Holman, Rebecca, van Kaam, Anton H
• Format: Article
• Language: English
• Subjects: Bronchopulmonary dysplasia; Bronchopulmonary Dysplasia - prevention & control; Clinical trials; Dosage and administration; Double-Blind Method; Drug dosages; Drug therapy; Ethics; FDA approval; Gestational age; Glucocorticoids; Health aspects; Human health sciences; Humans; Hydrocortisone; Hydrocortisone - adverse effects; Hydrocortisone - therapeutic use; Hydrocortisone/adverse effects/therapeutic use; Infant, Newborn; Infant, Premature; Lung diseases; Mortality; Newborn babies; Outcome Assessment (Health Care); Patients; Pediatrics; Premature babies; Premature birth; Preterm; Pédiatrie; Risk factors; Sample Size; Sciences de la santé humaine; Statistical analysis; Statistical analysis plan; Update; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2505-y

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. 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. Netherlands Trial Register, NTR2768 . Registered on 17 February 2011. EudraCT, 2010-023777-19. Registered on 2 November 2010.