NCT01291654

Paracetamol and Patent Ductus Arteriosus (PDA)

Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 2 Days – 2 Weeks
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Paracetamol	po Paracetamol 15 mg/kg every 6 hours x 3 days
DRUG	NSAID	IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; 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).
DRUG	D5W	Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-12-01
• First posted: 2011-02-08
• Last updated: 2012-12-19

Locations

1 site across 1 country: Israel