NCT01536158

Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

Oral Paracetamol Versus Oral Ibuprofen Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 2 Days – 10 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Detailed description

To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants. Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours. One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Oral paracetamol	Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
DRUG	Oral ibuprofen	Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-02-20
• Last updated: 2012-12-27

Locations

1 site across 1 country: Turkey (Türkiye)