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Sponsored by: |
Shaare Zedek Medical Center |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00616382 |
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 | Intervention | Phase |
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Patent Ductus Arteriosus |
Drug: Indomethacin Drug: Pentoxifylline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates |
Estimated Enrollment: | 68 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stepwise Indo: Experimental
Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
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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.
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PTX: Experimental
Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha
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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 |
Ages Eligible for Study: | up to 4 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathy Hammerman, MD | 9722 6666238 | cathy@cc.huji.ac.il |
Israel | |
Neonatal Intensive Care Unit - Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 |
Principal Investigator: | Cathy Hammerman, MD | Shaare Zedek Medical Center |
Responsible Party: | Shaare Zedek Medical Center ( Cathy Hammerman ) |
Study ID Numbers: | CHPDA2 |
Study First Received: | January 13, 2008 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00616382 History of Changes |
Health Authority: | Israel: Ministry of Health |
PDA indomethacin pentoxifylline Patent Ductus Arteriosus [PDA] resistant to therapy |
Anti-Inflammatory Agents Birth Weight Vasodilator Agents Radiation-Protective Agents Antioxidants Heart Diseases Cardiovascular Abnormalities Patent Ductus Arteriosus Cyclooxygenase Inhibitors Cardiovascular Agents Pentoxifylline Body Weight |
Phosphodiesterase Inhibitors Analgesics, Non-Narcotic Indomethacin Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Congenital Abnormalities Antirheumatic Agents Heart Defects, Congenital Ductus Arteriosus, Patent |
Anti-Inflammatory Agents Vasodilator Agents Radiation-Protective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Reproductive Control Agents Gout Suppressants Pentoxifylline Tocolytic Agents Sensory System Agents Therapeutic Uses Free Radical Scavengers Indomethacin |
Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Congenital Abnormalities Ductus Arteriosus, Patent Heart Diseases Cardiovascular Abnormalities Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Analgesics, Non-Narcotic Platelet Aggregation Inhibitors |