Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
NCT05049330 · View on ClinicalTrials.gov ↗
Study Summary
Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.
Conditions Studied
Study Locations (18)
California
- Children's Hospital Los Angeles — Los Angeles
- UCSF Benioff Children's Hospital — Oakland
- Children's Hospital UC Davis Health — Sacramento
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Nationwide Children's Hospital — Columbus
- The Ohio State University — Columbus
Pennsylvania
- UT Southwestern Medical Center — Dallas
- Children's Hospital of Philadelphia — Philadelphia
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Colorado
- Children's Hospital Colorado — Denver
District of Columbia
- Children's National Medical Center — Washington D.C.
Georgia
- Children's Healthcare of Atlanta — Atlanta
Massachusetts
- Boston Children's Hospital — Boston
Michigan
- CS Mott Children's Hospital — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,222 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2026-09-01 |
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 NCT05049330
The ClinicalTrials.gov registry entry for NCT05049330 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 22,222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Julie Leonard, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cervical Spine Injury appearing as the primary indexed condition, and to 0 interventions. 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: NCT05049330 reports 18 study locations spanning 12 distinct geographic areas — top geographies include California, Ohio, Pennsylvania. 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 NCT05049330 about?
NCT05049330 is a clinical study titled "Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool". Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patien...
What is the current status of trial NCT05049330?
This trial is currently recruiting. The enrollment target is 22,222 participants. The study started on 2018-12-12. Estimated completion is 2026-09-01.
What conditions does trial NCT05049330 study?
This clinical trial studies the following conditions: Cervical Spine Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT05049330?
This trial is sponsored by Julie Leonard, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05049330 being conducted?
This trial has 18 study locations across California, Colorado, District of Columbia, Georgia, Massachusetts. 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.