NCT00833365

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 96 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus
• Prematurity

Interventions

Type	Name	Description
DRUG	Ibuprofen	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
DRUG	Ibuprofen	Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-02-02
• Last updated: 2016-07-04
• Results posted: 2016-07-04

Locations

1 site across 1 country: United States