NCT00961753

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

Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OSF Healthcare System · Academic / Other
• Sex: All
• Age: 1 Day – 29 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	optimized ibuprofen	day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals
DRUG	Standard Ibuprofen	day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-08-19
• Last updated: 2014-01-28

Locations

1 site across 1 country: United States