NCT03265782

Paracetamol Versus Ibuprofen for PDA Closure

Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 28 Weeks – 35 Weeks
• Healthy volunteers: Not accepted

Summary

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Detailed description

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct. Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	ibuprofen	drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
DRUG	paracetamol	drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-09-01
• Completion: 2018-01-01
• First posted: 2017-08-29
• Last updated: 2017-08-29