Early Versus Late Use of Ibuprofen for PDA Closure
The primary objective is to evaluate the 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.
The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The investigators believe that early ibuprofen will blunt the stress response greater than later use.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early vs. Late Use of Ibuprofen for PDA Closure and Pain/Stress Reduction|
- The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu). [ Time Frame: Within 48 hrs of ibuprofen round ] [ Designated as safety issue: No ]
- The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. [ Time Frame: 1 hr prior to initial dose, and then 1 and 6 hrs post initial dose of ibuprofen ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Early treatment
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose
Other Name: NeoProfen
Active Comparator: Late treatment
Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
Other Name: NeoProfen
Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a 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.
Stress response will be evaluated by drawing catecholamines, glucose, and lactate at one hour prior to initial dose of ibuprofen, and then at 1 and 6 hours post initial ibuprofen dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833365
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Gary Chan, MD||University of Utah|