Paracetamol Versus Ibuprofen for PDA Closure

Study Overview
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Brief Summary
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Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Detailed Description
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A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct. Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Official Title
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Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: ibuprofen
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age ≤ 35 weeks Aged 2-7 days with color Doppler echocardiographic evidence of PDA Urine output more than 1 ml/kg/hr Creatinine concentration level less than 1.8 mg/dl Exclusion Criteria: Neonates who have one or more of the following criteria were excluded from the study: Congenital heart diseases of any type including Pulmonary stenosis Anomalus in pulmonary venous drainage Ventricular septal defect Major congenital anomalies as hydrops fetalis Low platelets count (less than 60, 000/mm3)

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 35 Weeks

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen group<br>treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done | Drug: ibuprofen<br>* drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days<br>* Other names: brufen;|
| Experimental: paracetamol group<br>treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done | Drug: paracetamol<br>* drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days<br>* Other names: cetal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closure of PDA | Echo confirmed closure | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, paracetamol, ibuprofen, PDA, preterms, efficacy