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A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
NCT05910567 · View on ClinicalTrials.gov ↗
Study Summary
Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Focused Assessment with Sonography for Trauma (FAST) Examination
- OTHER No Intervention: Standard of Care - Without the FAST Examination
Study Locations (6)
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- The Research Institute at Nationwide Children's Hospital — Columbus
California
- University of California, Davis Medical Center — Sacramento
Colorado
- University of Colorado, Anschutz Medical Center and Children's Hospital Colorado — Aurora
Georgia
- Emory University Children's Healthcare of Atlanta — Atlanta
Texas
- University of Texas Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,346 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05910567
The ClinicalTrials.gov registry entry for NCT05910567 describes a study currently listed as recruiting. It is categorized as NA, 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 4,346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 653 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Wounds and Injuries appearing as the primary indexed condition, and to 2 interventions — of which Focused Assessment with Sonography for Trauma (FAST) Examination 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: NCT05910567 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Ohio, California, Colorado. 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 NCT05910567 about?
NCT05910567 is a clinical study titled "A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma". Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and t...
What is the current status of trial NCT05910567?
This trial is currently recruiting. It is a NA study. The enrollment target is 4,346 participants. The study started on 2023-04-17. Estimated completion is 2027-04-30.
What conditions does trial NCT05910567 study?
This clinical trial studies the following conditions: Wounds and Injuries, Abdominal Injury, Blunt Trauma to Abdomen, Abdomen Injury, Abdomen, Acute. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05910567?
The interventions under investigation include: Focused Assessment with Sonography for Trauma (FAST) Examination (DIAGNOSTIC_TEST), No Intervention: Standard of Care - Without the FAST Examination (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05910567?
This trial is sponsored by University of California, Davis, which has 653 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05910567 being conducted?
This trial has 6 study locations across California, Colorado, Georgia, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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