Status:
UNKNOWN
Treating the Resistant Patent Ductus Arteriosus (PDA)
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
2-4 years
Phase:
PHASE2
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 paten...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00616382
Start Date
March 1 2008
Last Update
February 15 2008
Active Locations (1)
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1
Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Jerusalem, Israel, 91031