NCT01261117

Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants

Oral Versus Intravenous Ibuprofen Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

Summary

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

Detailed description

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. 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 ibuprofen treatment.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	oral ibuprofen	oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2010-12-16
• Last updated: 2011-08-09

Locations

1 site across 1 country: Turkey (Türkiye)