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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Treatments: Acetaminophen; Ibuprofen

Criteria

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