Treating the Resistant Patent Ductus Arteriosus (PDA)

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Treating the Resistant Patent Ductus Arteriosus (PDA)

Official Title

New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.

Condition

Patent Ductus Arteriosus

Intervention

Indomethacin

Study Arms / Comparison Groups

 Stepwise Indo
Description:  Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

68

Start Date

March 2008


Primary Completion Date

March 2010

Eligibility Criteria

        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).
      

Gender

All

Ages

N/A - 4 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Cathy Hammerman, MD, 9722 6666238, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00616382

Organization ID

CHPDA2



Study Sponsor

Shaare Zedek Medical Center


Study Sponsor

Cathy Hammerman, MD, Principal Investigator, Shaare Zedek Medical Center


Verification Date

January 2008