Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)

Study Overview
=================
Brief Summary
-----------------
The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

Detailed Description
-----------------
Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

Official Title
-----------------
Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Drug: Oral Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term newborn (37 weeks of gestation or more) Age between 20-28 days confirmed diagnosis of PDA by echocardiography by pediatric cardiologist Exclusion Criteria: Asphyxia Hemorrhage Platelet count < 150000 renal or gastrointestinal malformations associated congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Days
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Ibuprofen<br>10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated. | Drug: Oral Ibuprofen<br>* 10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.<br>* Other names: Advil;|
| No Intervention: No treatment<br>No treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDA closure after 1 week | PDA closure after 1 week of treatment based on echocardiography | 1 weeks after treatment | 
| PDA closure after two weeks | PDA closure two weeks after treatment based on echocardiography | 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug side effects | hemorrhage, abdominal distention, oliguria | two weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patent Ductus Arteriosus, PDA, Term newborns, Ibuprofen