Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes.

ABSTRACT:

Background

The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analysis plan for the short-term health outcomes of the Baby-OSCAR trial.

Methods and design

This is a randomised controlled trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies improves short and long-term health and economic outcomes. Infants born between 23⁺⁰ and 28⁺⁶ weeks of gestation, confirmed by echocardiography as having a large PDA (with a diameter of at least 1.5 mm and unrestricted pulsatile PDA flow pattern), with parental informed consent

SUBMITTER: Bell JL 

PROVIDER: S-EPMC8157743 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature