Status:
COMPLETED
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
Lead Sponsor:
Hormozgan University of Medical Sciences
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
20-28 years
Phase:
NA
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 Ib...
Eligibility Criteria
Inclusion
- Term newborn (37 weeks of gestation or more)
- Age between 20-28 days
- confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
Exclusion
- Asphyxia
- Hemorrhage
- Platelet count \< 150000
- renal or gastrointestinal malformations
- associated congenital heart disease
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01511887
Start Date
January 1 2011
End Date
January 1 2012
Last Update
January 20 2012
Active Locations (1)
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1
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran, 097145-3388