NCT01544972

Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants

Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• 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 oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

Detailed description

To determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels 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 for 3 days. 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. Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained. The relation of pharmacokinetics of drugs to drug response will be evaluated

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Oral paracetamol	Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
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: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-06
• Last updated: 2012-12-17

Locations

1 site across 1 country: Turkey (Türkiye)