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

This study has been withdrawn prior to enrollment.
(Changes in approach to PDA therapy)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01070745
First received: February 17, 2010
Last updated: June 6, 2012
Last verified: February 2010

February 17, 2010
June 6, 2012
June 2010
June 2012   (final data collection date for primary outcome measure)
Improvement in ductal closure rates in those infants who do not respond to a first course of therapy [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01070745 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)
Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Patent Ductus Arteriosus
  • Drug: Indomethacin
    Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
    Other Name: Indomed
  • Drug: Ibuprofen
    10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
    Other Name: Arfen
  • Experimental: Indomethacin for resistant PDA
    Treatment with second course of indomethacin
    Intervention: Drug: Indomethacin
  • Experimental: Ibuprofen for resistant PDA
    Ibuprofen as second course of therapy
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
June 2012   (final data collection date for primary outcome measure)

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).
Both
up to 2 Months
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01070745
chammerman3
Yes
Dr. Cathy Hammerman, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Investigator
Shaare Zedek Medical Center
February 2010

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