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

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: H. Lundbeck A/S
• Treatments: Ibuprofen

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