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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 4

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Oral ibuprofen; Drug: Oral paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01536158

ZTB150212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 2 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Oral paracetamol

Active Comparator group

Description:

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.

Treatment:

Drug: Oral paracetamol

Oral ibuprofen

Active Comparator group

Description:

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Treatment:

Drug: Oral ibuprofen