Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

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

Brief Title

Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

Official Title

Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction

Brief Summary

      The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early
      vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a
      higher PDA closure rate than later use of Ibu. Early use is defined as medication given
      before the infant reaches 96 hrs old. Late use is defined as medication given when infant is
      more than 96 hrs old.
    

Detailed Description

      Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with
      a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to
      treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old.
      Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5
      mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done
      prior to treatment and then within 48 hours after treatment.
    


Study Type

Interventional


Primary Outcome

Number of PDA Closures Related to Treatment With Ibuprofen

Secondary Outcome

 Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration

Condition

Patent Ductus Arteriosus

Intervention

Ibuprofen

Study Arms / Comparison Groups

 Early treatment
Description:  Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

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

15

Start Date

January 2009

Completion Date

November 2011

Primary Completion Date

November 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Birth weight less than 1200gm

          -  Less than 28 weeks gestational age

          -  Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

        Exclusion Criteria:

          -  Active Bleeding

          -  Currently being treated for Persistent Pulmonary Hypertension (PPHN)

          -  Cardiac anomalies

          -  Chromosomal abnormalities

          -  Endocrine, metabolic, renal, or hepatic disorders
      

Gender

All

Ages

N/A - 96 Hours

Accepts Healthy Volunteers

No

Contacts

Gary Chan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00833365

Organization ID

31394


Responsible Party

Sponsor

Study Sponsor

University of Utah

Collaborators

 H. Lundbeck A/S

Study Sponsor

Gary Chan, MD, Principal Investigator, University of Utah


Verification Date

December 2014