Treating the Resistant Patent Ductus Arteriosus (PDA)
Information source: Shaare Zedek Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Intervention: Indomethacin (Drug); Pentoxifylline (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Shaare Zedek Medical Center Official(s) and/or principal investigator(s):
Cathy Hammerman, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center
Overall contact:
Cathy Hammerman, MD, Phone: 9722 6666238, Email: cathy@cc.huji.ac.il
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.
Clinical Details
Official title: New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.
Secondary outcome: Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.To monitor and compare potential side effects of the two treatment approaches
Eligibility
Minimum age: N/A.
Maximum age: 4 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Inborn premature neonates admitted to the neonatal intensive care unit of the Shaare
Zedek Medical Center and diagnosed as having a hemodynamically significant patent
ductus arteriosus (sPDA) will be considered as potential candidates for study if/when
they do not respond to initial therapy
Exclusion Criteria:
- Any baby not considered viable
- Any baby with IVH grade 3-4 of recent onset (within 3 days. [If no head ultrasound
has been performed within the last 3-4 days, one should performed prior to onset of
study.]
- Any baby with dysmorphic features or congenital abnormalities
- Any baby with structural heart disease other than PDA
- Any baby with documented infection,
- Any baby with thrombocytopenia (<50,000).
Locations and Contacts
Cathy Hammerman, MD, Phone: 9722 6666238, Email: cathy@cc.huji.ac.il
Neonatal Intensive Care Unit - Shaare Zedek Medical Center, Jerusalem 91031, Israel
Additional Information
Starting date: March 2008
Last updated: February 14, 2008
|
