Paracetamol and Patent Ductus Arteriosus (PDA)

Patent Ductus Arteriosus Clinical Trial

Official title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate

Status Recruiting

Clinical Trial Summary

The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.

Clinical Trial Description

Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

• NCT number: NCT01291654
• Study type: Interventional
• Source: Shaare Zedek Medical Center
• Contact: Cathy Hammerman, MD
• Phone: +9722666-6238
• Email: cathy@cc.huji.ac.il
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2012