Conditions: Patent Ductus Arteriosus Prematurity
Keywords: premature infants PDA ibuprofen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

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.

Arms:
arm 1: Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old arm 2: 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.

Interventions: intervention 1: Ibuprofen intervention 2: Ibuprofen
Intervention descriptions: intervention 1: 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 intervention 2: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Protocol document: