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NCT01958320 · ClinicalTrials.gov registry record · Phase 2
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
A Phase 2 study of Surgery and Necrotizing Enterocolitis, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
- 18
- Study locations
NCT01958320: Completed Phase 2 study of Surgery and Necrotizing Enterocolitis, sponsored by University of California, San Francisco.
NCT01958320 is a Phase 2 study of Surgery and Necrotizing Enterocolitis that has completed, run by University of California, San Francisco. The registered enrollment target is 202 participants, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958320, a Phase 2 study of Surgery and Necrotizing Enterocolitis, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
- 18
- Study locations
Study Summary
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth. The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".
Primary Outcome
Number of infants who undergo in hospital PDA ligations or who have an open ductus at the time of discharge (that need future outpatient cardiology follow-up visits)
Conditions Studied
Interventions
- DRUG NSAID
- OTHER pharmacologic treatment of the PDA
- OTHER no pharmacologic treatment of the PDA
Study Locations (18)
California
- University of California San Diego - San Diego
- Sharp Mary Birch Hospital for Women and Newborns - San Diego
- University of California San Francisco - San Francisco
- Mednax Neonatology of San Jose/Pediatrix Medical Group - San Jose
- Kaiser Permanente Santa Clara - Santa Clara
Other
- University Hospital, Umea, Sweden - Umeå
- Ankara University School of Medicine Children's Hospital - Ankara
- Sisli Hamidiye Etfal Training and Research Hospital - Istanbul
- Inonu University School of Medicine Turgut Ozal Medical Center - Malatya
Illinois
- University of Chicago Medicine - Chicago
- Northshore University Health System - Evanston
Florida
- South Miami Hospital - Miami
Maryland
- Johns Hopkins University - Baltimore
Minnesota
- Mayo Clinic - Rochester
New Jersey
- Morristown Medical Center - Morristown
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
What the finished NCT01958320 record still lists
NCT01958320 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Surgery appearing as the primary indexed condition, and to 3 interventions - of which NSAID is the first listed.
NCT01958320 lists 18 locations in 10 states (California, Other, Illinois).
Frequently Asked Questions
What is clinical trial NCT01958320 about?
NCT01958320 is a clinical study titled "Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus". The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/...
What is the current status of trial NCT01958320?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2013-12. Estimated completion is 2017-06.
What conditions does trial NCT01958320 study?
This clinical trial studies the following conditions: Surgery, Necrotizing Enterocolitis, Patent Ductus Arteriosus, Intestinal Perforation.
What interventions are being tested in trial NCT01958320?
The interventions under investigation include: NSAID (DRUG), pharmacologic treatment of the PDA (OTHER), no pharmacologic treatment of the PDA (OTHER).
Who is sponsoring clinical trial NCT01958320?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01958320 being conducted?
This trial has 18 study locations across California, Florida, Illinois, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01958320's enrollment target sits among peer trials
202 39th of 120 higher than 81 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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