Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
NCT01958320 · View on ClinicalTrials.gov ↗
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".
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01958320
The ClinicalTrials.gov registry entry for NCT01958320 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01958320 reports 18 study locations spanning 10 distinct geographic areas — top geographies include California, Other, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01958320?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.