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Treating the Resistant Patent Ductus Arteriosus (PDA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00616382
First received: January 13, 2008
Last updated: February 14, 2008
Last verified: January 2008
History of Changes
January 13, 2008
February 14, 2008
March 2008
March 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols. [ Time Frame: 2 years ]
  • To monitor and compare potential side effects of the two treatment approaches [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Treating the Resistant Patent Ductus Arteriosus (PDA)
New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Patent Ductus Arteriosus
  • 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.
  • 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
  • Experimental: Stepwise Indo
    Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
    Intervention: Drug: Indomethacin
  • Experimental: PTX
    Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha
    Intervention: Drug: Pentoxifylline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
68
Not Provided
March 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
up to 4 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00616382
CHPDA2
Yes
Not Provided
Not Provided
Cathy Hammerman, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP