ETAPA

The objective of the study is to determine whether, among extremely low birth weight (ELBW - birth weight less than 1000g) infants, early targeted treatment with Paracetamol for patent ductus arteriosus (PDA), based on specific criteria and commencing between six to twelve hours of life, results in significant reduction of a combined primary outcome of periventricular and intraventricular haemorrhage (PIVH), necrotising enterocolitis (NEC) and death before discharge. The Trial design is a Phase 3 randomised, parallel-group, placebo-controlled trial.

Analysis will be carried out as intention to treat. For the analysis of the primary end point a mixed-effects logistic regression model will be used. The fixed covariates will be the treatment group and weight as a continuous variable. The centre will be included in the model as a random intercept (i.e. fixed + random effects = mixed effects), which will adjust for centre-specific variance. By this approach a precision and statistical power will be gained (with potential ability to describe smaller, but significant effects). The trial statistician will prepare a Statistical Analysis Plan.

A sample size of 218 infants is needed with 109 infants in each arm, (using corrected chi-square test and Fischer’s Exact test), to decrease the rate of our combined outcome from 32% to 15% (17% absolute reduction), with alpha 5% and 80% power.

Population: paediatric | Intervention type: therapeutic procedural