Clinical Trial: Treating the Resistant Patent Ductus Arteriosus (PDA)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
Brief 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.
Detailed Summary:
Sponsor: Shaare Zedek Medical Center
Current Primary Outcome: Our primary objective in this study is to improve ductal closure rates in those infants who do not respond to a first course of therapy. [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols. [ Time Frame: 2 years ]
- To monitor and compare potential side effects of the two treatment approaches [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Shaare Zedek Medical Center
Dates:
Date Received: January 13, 2008
Date Started: March 2008
Date Completion:
Last Updated: February 14, 2008
Last Verified: January 2008
