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

Overview

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 Title of Study: “Oral Paracetamol Versus Oral Ibuprofen Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2012

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.

Interventions

  • Drug: Oral paracetamol
    • Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Oral paracetamol
    • Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
    • Time Frame: Until discharge
    • To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment

Secondary Measures

  • Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Days

Maximum Age: 10 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zekai Tahir Burak Women’s Health Research and Education Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital – Zekai Tahir Burak Women’s Health Research and Education Hospital
  • Overall Official(s)
    • Mehmet Yekta Oncel, MD, Principal Investigator, Zekai Tahir Burak Women’s Health Research and Education Hospital

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