Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSF Healthcare System
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation

• Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt

• Signed informed consent

Exclusion Criteria:

• Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,

• Active bleeding (including Grade 3 or 4 IVH)

• Platelet count < 100,000

• Coagulopathy

• Suspected NEC

• Suspected perforation

• Creatinine > 1.5

• Hyperbilirubinemia requiring exchange transfusion

• Hypotension requiring pressor support

• Life-threatening congenital malformation