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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Paracetamol Versus Oral Ibuprofen Treatment

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: Oral paracetamol
* Drug: Oral ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral paracetamol<br>Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours. | Drug: Oral paracetamol<br>* Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.<br>* Other names: Calpol;|
| Active Comparator: Oral ibuprofen<br>Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. | Drug: Oral ibuprofen<br>* Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.<br>* Other names: Pedifen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen | To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment | Until discharge | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant