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

Phase 4

Completed

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

• Registration Number: NCT01536158
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Primary Completion: 2012-11
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-24
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• 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
• Urine output of less than 1 ml/kg/h during the preceding 8 h,
• Serum creatinine level >1.6 mg/dl,
• Platelet count <60,000/mm3,
• Liver failure,
• Hyperbilirubinemia requiring exchange transfusion
• 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.
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
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen	Until discharge	To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment

Secondary Outcome Measures

Name	Time	Method
Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants	corrected 36 weeks or until discharge	Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.

Trial Locations

Locations (1)

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