drugset / Trial / NCT00187447

Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

NCT00187447

Phase 2 Completed 100 enrolled University of California, San Francisco
RandomizedSingle-groupDouble-blindPrevention

Summary

The purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects. The long term objective is to find the optimal dosing of indomethacin for permanent closure of the Ductus and prevent the morbidity related to PDA and the complications of surgical ligation.

Timeline

Start
2003-08
Primary completion
2006-07
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 0.1 mg/kg
Subject Indomethacin Small molecule 0.25 mg/kg