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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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.
Sponsor: Hormozgan University of Medical Sciences

Current Primary Outcome:

  • PDA closure after 1 week [ Time Frame: 1 weeks after treatment ]
    PDA closure after 1 week of treatment based on echocardiography
  • PDA closure after two weeks [ Time Frame: 2 weeks after treatment ]
    PDA closure two weeks after treatment based on echocardiography


Original Primary Outcome: Same as current

Current Secondary Outcome: Drug side effects [ Time Frame: two weeks after treatment ]

hemorrhage, abdominal distention, oliguria


Original Secondary Outcome: Same as current

Information By: Hormozgan University of Medical Sciences

Dates:
Date Received: January 13, 2012
Date Started: January 2011
Date Completion:
Last Updated: January 19, 2012
Last Verified: January 2012