Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)

Phase 2

Withdrawn

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

• Registration Number: NCT01070745
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.

However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.

As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-06
• Primary Completion: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Inborn premature neonates (birth weight [BW] <1500 grams) being treated in the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hsPDA) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent.

Exclusion Criteria

• Any baby not considered viable
• Any baby with intraventricular hemorrhage (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 be 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
Ibuprofen for resistant PDA	Ibuprofen	Ibuprofen as second course of therapy
Indomethacin for resistant PDA	Indomethacin	Treatment with second course of indomethacin

Primary Outcome Measures

Name	Time	Method
Improvement in ductal closure rates in those infants who do not respond to a first course of therapy	2.5 years

Secondary Outcome Measures

Name	Time	Method
More infants who did not respond to a first course of therapy with indomethacin who respond to a second course with ibuprofen than to a repeat course of indomethacin	2.5 years
Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects	2.5 years

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel