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