drugset / Trial / NCT00616382

Treating the Resistant Patent Ductus Arteriosus (PDA)

NCT00616382

Phase 2 Unknown 68 enrolled Shaare Zedek Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure. Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure in approximately 70% of treated infants. In a recent study in our population, 17% of the babies showed no ductal response to the first course of treatment and 9.4% of our study infants eventually underwent surgical ligation of the ductus after failure of medical therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches to ductal closure in babies who do not respond to initial therapy.

Timeline

Start
2008-03
Primary completion
2010-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 0.2 mg/kg Intravenous
Subject Indomethacin Small molecule 1 mg/kg Intravenous
Subject Pentoxifylline Small molecule 5 mg/kg