RecruitingACTRN12621001050842

Study Of Neck Injuries In Children (SONIC)

Study Of Neck Injuries In Children (SONIC): A prospective observational study to validate existing international clinical decision rules for children presenting to the emergency department with suspected cervical spine injuries

Sponsor

Murdoch Children's Research Institute

Enrollment

30,000 participants

Start Date

Sep 7, 2021

Study Type

Observational

Conditions

cervical spine injury

Summary

This study aims to externally validate existing international adult and paediatric clinical decision rules (CDRs) designed to guide emergency clinician imaging decisions in a large cohort of Australian and New Zealand children presenting with suspected cervical spine injury. It aims to assess (i) their accuracy in detecting cervical spine injury (CSI) (ii) their ability to accurately identify children who do not need cervical spine imaging and (iii) their cost-effectiveness. An exploratory analysis of the data will also be conducted to determine whether a new paediatric CDR can be derived and validated to improve accurate detection of CSI and/or risk stratification of children with suspected CSI into those who do and do not require imaging. This study is expected to identify the most child appropriate CDR. The epidemiology and outcomes of CSI in this cohort of children will also be described.

Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating the best way to assess potential neck injuries in children who have had a fall or other blunt trauma. Currently, doctors use a range of 'decision rules' to decide whether a child needs a neck X-ray or scan — but most of these rules were designed for adults, and it is unclear how well they work for children. The SONIC study (Study Of Neck Injuries In Children) is collecting data from a large group of Australian and New Zealand children who come to emergency departments with suspected cervical spine injuries. By comparing how well different existing decision tools perform — and exploring whether a new, child-specific tool can be developed — the study aims to reduce unnecessary imaging while making sure genuine injuries are not missed. The study is open to children under 16 years of age who have had a known or suspected blunt trauma and are being assessed for a possible neck injury. It is an observational study, meaning children receive their normal medical care — the research team simply records information about their assessment and outcome.

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Interventions

Details of clinical history, examination and management (including imaging and any surgical interventions) will be recorded for all patients presenting to the Emergency department (ED) with a possible cervical spine injury (CSI). The primary outcome variable of interest is the presence or absence of CSI. Data will be used to validate existing clinical decision rules (CDRs) for use in possible CSI. The CDRs to be validated will be 1. National Emergency X-radiography Utilization Study (NEXUS) Low risk Criteria (Hoffman et al 2001 NEJM; Viccellio et al. 2001 Pediatrics) 2. Canadian C-Spine Rule (CCR) (Stiell 2001 JAMA) 3. Pediatric Emergency Care Applied Research Network (PECARN) risk criteria -these risk criteria are evolving, we will use the latest criteria as published or provided by the PECARN investigators (Leonard et al 2011 Ann Emerg Med; Leonard et al 2019 Pediatrics). The predictor variables of the clinical decision rules will be collected at the time of ED presentation. Data will be obtained from: 1. Information provided by the initial treating clinician in ED 2. Review of the patient medical records after 21 days 3. Follow up phone call to the Guardian/participants who do not receive cervical spine imaging for their injury presentation 21-60 days post ED presentation with appropriate consent. This study is an observational study and participants will receive routine clinical care. Information will be obtained during routine clinical assessments. Eligible participants will be enrolled across a 4 year period. Data analysis for primary and secondary outcomes will be performed once all data have been collected with no plan for an interim analysis.