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

NCT01070745 | Withdrawn Phase 2 DMC

• 1 other identifier: chammerman3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

PDA; Indomethacin; Ibuprofen

Outcome Measures

Primary Outcomes (1)

• Improvement in ductal closure rates in those infants who do not respond to a first course of therapy

  2.5 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Indomethacin for resistant PDA

EXPERIMENTAL

Treatment with second course of indomethacin

Drug: Indomethacin

Ibuprofen for resistant PDA

EXPERIMENTAL

Ibuprofen as second course of therapy

Drug: Ibuprofen

Interventions

Indomethacin DRUG

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

Also known as: Indomed

Indomethacin for resistant PDA

Ibuprofen DRUG

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

Also known as: Arfen

Ibuprofen for resistant PDA

Eligibility Criteria

• Age: 2 Days - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Indomethacin; Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Cathy Hammerman, MD

  Shaare Zedek Medical Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Last Updated: June 7, 2012

Record last verified: 2010-02

Locations

IL (1)