NCT02002741

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 2 Days – 2 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Detailed description

Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Conditions

• Ductus Arteriosus, Patent

Interventions

Type	Name	Description
DRUG	Paracetamol	Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
DRUG	Placebo	Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-05-31
• Completion: 2017-12-31
• First posted: 2013-12-06
• Last updated: 2020-02-18

Locations

1 site across 1 country: Israel