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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