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

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

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