Overview

Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

Status:
Suspended
Trial end date:
2019-10-31
Target enrollment:
Participant gender:
Summary
Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Padova
University of Padua
Treatments:
Acetaminophen
Ibuprofen