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Treating the Resistant Patent Ductus Arteriosus (PDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616382
Recruitment Status : Unknown
Verified January 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2008
Last Update Posted : February 15, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Indomethacin Drug: Pentoxifylline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
Study Start Date : March 2008
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Stepwise Indo
Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
Drug: Indomethacin
IV indomethacin starting at a dose of 0.4 mg/kg given over 30 minutes, increased daily by increments of 0.2 mg/kg/dose and given at intervals of 12 hours until a maximum dose of 1 mg/kg is reached, or until a total indomethacin dose of 6 mg/kg has been given. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later, using the same dose used in the last indomethacin infusion.

Experimental: PTX
Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha
Drug: Pentoxifylline
IV indomethacin will be re-started at a dose of 0.2 mg/kg to run over 30 minutes at 12 hour intervals to be given concurrently with pentoxifylline (5 mg/kg/hour to run over 6 hour once a day for a maximum of 6 days. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later and another day of pentoxifylline infusion, provided that the 6 day maximum has not yet been

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols. [ Time Frame: 2 years ]
  2. To monitor and compare potential side effects of the two treatment approaches [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616382

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Contact: Cathy Hammerman, MD 9722 6666238

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Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Principal Investigator: Cathy Hammerman, MD         
Sub-Investigator: Irina Schorrs, MD         
Sub-Investigator: Amiram Nir, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

Publications of Results:
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Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center Identifier: NCT00616382    
Other Study ID Numbers: CHPDA2
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: January 2008
Keywords provided by Shaare Zedek Medical Center:
Patent Ductus Arteriosus [PDA] resistant to therapy
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Vasodilator Agents
Free Radical Scavengers