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

Brief Title

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

Official Title

Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates

Brief Summary

      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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Improvement in ductal closure rates in those infants who do not respond to a first course of therapy

Secondary Outcome

 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

Condition

Patent Ductus Arteriosus

Intervention

Indomethacin

Study Arms / Comparison Groups

 Indomethacin for resistant PDA

Description:  Treatment with second course of indomethacin

Publications

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

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

June 2010

Primary Completion Date

June 2012

Eligibility 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).
      

Gender

All

Ages

N/A - 2 Months

Accepts Healthy Volunteers

No

Contacts

Cathy Hammerman, MD, , 

Location Countries

Israel

Location Countries

Israel

NCT ID

NCT01070745

Organization ID

chammerman3

Study Sponsor

Shaare Zedek Medical Center

Study Sponsor

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

Verification Date

February 2010