Brief Title
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
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
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.
Study Type
Interventional
Primary Outcome
PDA closure after 1 week
Secondary Outcome
Drug side effects
Condition
Patent Ductus Arteriosus
Intervention
Oral Ibuprofen
Study Arms / Comparison Groups
Oral Ibuprofen
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
January 2011
Completion Date
January 2012
Primary Completion Date
December 2011
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
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Hamidreza Mahboobi, MD, ,
Location Countries
Iran, Islamic Republic of
Location Countries
Iran, Islamic Republic of
Administrative Informations
NCT ID
NCT01511887
Organization ID
Ibuprofen in PDA
Responsible Party
Principal Investigator
Study Sponsor
Hormozgan University of Medical Sciences
Study Sponsor
Hamidreza Mahboobi, MD, Principal Investigator, Hormozgan University of Medical Sciences (HUMS)
Verification Date
January 2012