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

NCT ID: NCT01070745

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30

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.

Conditions

Patent Ductus Arteriosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Indomethacin for resistant PDA

Treatment with second course of indomethacin

Group Type: EXPERIMENTAL

Indomethacin

Intervention Type: DRUG

Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours

Ibuprofen for resistant PDA

Ibuprofen as second course of therapy

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals

Interventions

Indomethacin

Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours

Intervention Type: DRUG

Ibuprofen

10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals

Intervention Type: DRUG

Other Intervention Names

Indomed; Arfen

Eligibility Criteria

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).

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shaare Zedek Medical Center

Principal Investigators

Cathy Hammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Investigator

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

chammerman3

Identifier Type: -

Identifier Source: org_study_id