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

Phase 4

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Oral paracetamol; Drug: Oral ibuprofen

• Registration Number: NCT01544972
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Birth weight below 1250 gram
• Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria

• Accompanied other congenital cardiac anomalies
• Severe thrombocytopenia < 60.000
• Severe intracranial bleeding (Grade III - IV)
• Intestinal abnormality and necrotising enterocolitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral paracetamol	Oral paracetamol	Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days
Oral ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA	up to 6 months	The measurement of Serum levels of Paracetamol and Ibuprofen in preterm infants treated with Oral Paracetamol and Oral Ibuprofen.; To determine of effective serum levels of paracetamol and ibuprofen for treatment of patent ductus arteriosus in preterm infants.; In normally, effective and safely dose of NSAIDs for treatment of PDA are exactly unknown. Therefore we will detected cut-off serum levels for effective, safely and hazardous.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology; 🇹🇷 Ankara, Turkey