Treating the Resistant Patent Ductus Arteriosus (PDA)
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ClinicalTrials.gov Identifier: NCT00616382 |
Recruitment Status
: Unknown
Verified January 2008 by Shaare Zedek Medical Center.
Recruitment status was: Not yet recruiting
First Posted
: February 15, 2008
Last Update Posted
: February 15, 2008
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Sponsor:
Shaare Zedek Medical Center
Information provided by:
Shaare Zedek Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | January 13, 2008 | |||
First Posted Date ICMJE | February 15, 2008 | |||
Last Update Posted Date | February 15, 2008 | |||
Study Start Date ICMJE | March 2008 | |||
Estimated Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treating the Resistant Patent Ductus Arteriosus (PDA) | |||
Official Title ICMJE | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Patent Ductus Arteriosus | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
68 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Estimated Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 4 Weeks (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00616382 | |||
Other Study ID Numbers ICMJE | CHPDA2 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Cathy Hammerman, Shaare Zedek Medical Center | |||
Study Sponsor ICMJE | Shaare Zedek Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Shaare Zedek Medical Center | |||
Verification Date | January 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |