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

This study has been withdrawn prior to enrollment.
(Changes in approach to PDA therapy)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01070745
First received: February 17, 2010
Last updated: June 6, 2012
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Patent Ductus Arteriosus
 Drug: Indomethacin
Drug: Ibuprofen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Improvement in ductal closure rates in those infants who do not respond to a first course of therapy [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2010
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin for resistant PDA
Treatment with second course of indomethacin
 Drug: Indomethacin
Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
Other Name: Indomed
Experimental: Ibuprofen for resistant PDA
Ibuprofen as second course of therapy
 Drug: Ibuprofen
10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
Other Name: Arfen

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070745

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Investigator
  More Information

No publications provided

Responsible Party: Dr. Cathy Hammerman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01070745     History of Changes
Other Study ID Numbers: chammerman3
Study First Received: February 17, 2010
Last Updated: June 6, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
PDA
Indomethacin
Ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013