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Management of the PDA Trial
NCT03456336 · View on ClinicalTrials.gov ↗
Study Summary
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
Conditions Studied
Interventions
- OTHER Active Treatment
- OTHER Expectant Management
Study Locations (19)
Ohio
- Cincinnati Children's Medical Center — Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland
- Research Institute at Nationwide Children's Hospital — Columbus
California
- Stanford University — Palo Alto
- Sharp Mary Birch Hospital for Women & Newborns — San Diego
North Carolina
- RTI International — Durham
- Duke University — Durham
Texas
- University of Texas Southwestern Medical Center at Dallas — Dallas
- University of Texas Health Science Center at Houston — Houston
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Emory University — Atlanta
Illinois
- Northwestern Lurie Children's Hospital of Chicago — Chicago
Iowa
- University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 836 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2027-05-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03456336
The ClinicalTrials.gov registry entry for NCT03456336 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 836 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 44 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 Infant, Premature appearing as the primary indexed condition, and to 2 interventions — of which Active Treatment 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: NCT03456336 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Ohio, California, North Carolina. 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 NCT03456336 about?
NCT03456336 is a clinical study titled "Management of the PDA Trial". Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
What is the current status of trial NCT03456336?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 836 participants. The study started on 2019-02-22. Estimated completion is 2027-05-30.
What conditions does trial NCT03456336 study?
This clinical trial studies the following conditions: Infant, Premature, Infant, Newborn, Diseases, Patent Ductus Arteriosus, Patent Ductus Arteriosus After Premature Birth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03456336?
The interventions under investigation include: Active Treatment (OTHER), Expectant Management (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03456336?
This trial is sponsored by NICHD Neonatal Research Network, which has 44 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03456336 being conducted?
This trial has 19 study locations across Alabama, California, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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