Treating the Resistant Patent Ductus Arteriosus (PDA)

Phase 2

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Indomethacin; Drug: Pentoxifylline

• Registration Number: NCT00616382
• Lead Sponsor: Shaare Zedek Medical Center

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 Description

Not available

Study Timeline

• Status Verified: 2008-01
• Study First Submitted: 2008-01-13
• Study First Submitted QC: 2008-02-14
• Last Update Submitted: 2008-02-14
• Study First Posted: 2008-02-15
• Last Update Posted: 2008-02-15
• Study Start: 2008-03
• Primary Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepwise Indo	Indomethacin	Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
PTX	Pentoxifylline	Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.	2 years
To monitor and compare potential side effects of the two treatment approaches	2 years

Trial Locations

Locations (1)

Neonatal Intensive Care Unit - Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel