drugset / Trial / NCT05493540

Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

NCT05493540

Phase 2 Completed 80 enrolled Nada Youssef
RandomizedParallel-groupTriple-blindTreatment

Summary

The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking. This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

Timeline

Start
2021-04-15
Primary completion
2022-08-15
Completion
2022-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule Oral