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Trial registered on ANZCTR


Registration number
ACTRN12621001050842
Ethics application status
Approved
Date submitted
11/05/2021
Date registered
10/08/2021
Date last updated
22/03/2022
Date data sharing statement initially provided
10/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Study Of Neck Injuries In Children (SONIC)
Scientific title
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
Secondary ID [1] 304123 0
Nil
Universal Trial Number (UTN)
Trial acronym
SONIC - Study of neck injuries in children
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical spine injury 321903 0
Condition category
Condition code
Emergency medicine 319540 319540 0 0
Other emergency care
Injuries and Accidents 320038 320038 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

Intervention code [1] 320459 0
Diagnosis / Prognosis
Comparator / control treatment
This study is an independent assessment in our setting of the performance accuracy (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of three existing clinical decision rules (CDRs)(NEXUS, Canadian C-spine, PECARN) for the assessment of possible cervical spine injury. There is no control group.
Control group
Active

Outcomes
Primary outcome [1] 327400 0
Sensitivity (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice

Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting study defined CSI. There is no gold standard.

Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra). The presence of CSI will be determined by review of the study site cervical spine imaging reports and if applicable, spine surgeon consultation notes and phone follow up.
Timepoint [1] 327400 0
At the conclusion of the study
Primary outcome [2] 328027 0
Specificity (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.

Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of study defined CSI.

Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).



Timepoint [2] 328027 0
At the conclusion of the study
Primary outcome [3] 328028 0
Negative predictive value (NPV) (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.

Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).

Timepoint [3] 328028 0
At the conclusion of the study
Secondary outcome [1] 394960 0
Positive predictive value (PPV) (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.

This is a further primary outcome.

Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).
Timepoint [1] 394960 0
At the conclusion of study
Secondary outcome [2] 394961 0
Sensitivity (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting clinically important CSI. There is no gold standard.

Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
Timepoint [2] 394961 0
At the conclusion of study
Secondary outcome [3] 394962 0
Specificity (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of clinically important CSI.

Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
Timepoint [3] 394962 0
At the conclusion of study
Secondary outcome [4] 394963 0
NPV (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
Timepoint [4] 394963 0
At the conclusion of study
Secondary outcome [5] 394964 0
PPV (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
Timepoint [5] 394964 0
At the conclusion of study
Secondary outcome [6] 394965 0
Sensitivity (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting CSI as defined by existing CDRs or risk criteria.
Timepoint [6] 394965 0
At the conclusion of study
Secondary outcome [7] 394966 0
Specificity (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice

Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of CSI as defined by existing CDRs or risk criteria.
Timepoint [7] 394966 0
At the conclusion of study
Secondary outcome [8] 394967 0
NPV (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Timepoint [8] 394967 0
At the conclusion of study
Secondary outcome [9] 394968 0
PPV (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice.
Timepoint [9] 394968 0
At the conclusion of study
Secondary outcome [10] 397598 0
Rate of study defined CSI.

Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).

The presence of study defined CSI will be determined for each enrolled participant following medical record review including cervical spine imaging reports, and if applicable spinal surgeon consultation notes and participant follow up.
Timepoint [10] 397598 0
At the conclusion of the study
Secondary outcome [11] 397599 0
Rate of Imaging-confirmed CSI

Imaging confirmed CSI is defined as formal radiology report of any trauma related radiological cervical spine abnormality on plain radiography (XR), Computed Tomography Scan (CT) or Magnetic resonance imaging (MRI). This includes vertebral fracture, facet joint subluxation or dislocation, ligamentous injury, disc injury, intra spinal haemorrhage (including subdural and extradural haemorrhage in the spinal canal)and spinal cord injury of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra, and C7-T1 disc).

The presence of imaging-confirmed CSI will be determined from medical record review for each participant.
Timepoint [11] 397599 0
At the conclusion of the study
Secondary outcome [12] 397600 0
Rate of clinically important CSI

Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.

The presence of study defined CSI will be determined for each enrolled participant following medical record review including cervical spine imaging reports, and if applicable spinal surgeon consultation notes and participant follow up.
Timepoint [12] 397600 0
At the conclusion of the study
Secondary outcome [13] 397601 0
Rate of CSI -related neurological abnormality.

The presence of study defined CSI will be determined for each enrolled participant following medical record review, and if applicable, spinal surgeon consultation notes.
Timepoint [13] 397601 0
At the conclusion of the study
Secondary outcome [14] 397602 0
Rate of surgical intervention of the cervical spine (as determined by clinical record review)
Timepoint [14] 397602 0
At the conclusion of the study
Secondary outcome [15] 397603 0
Determination of missed injury rate, if any, with x-ray (XR)
Timepoint [15] 397603 0
At the conclusion of the study
Secondary outcome [16] 397604 0
Determination of missed injury rate, if any, with computed tomography (CT)
Timepoint [16] 397604 0
At the conclusion of the study
Secondary outcome [17] 397605 0
Determination of missed injury rate, if any, with magnetic resonance imaging (MRI).
Timepoint [17] 397605 0
At the conclusion of the study
Secondary outcome [18] 397606 0
Methods of cervical spine immobilisation used

Methods of immobilisation will be determined by information provided by the initial treating clinician, and if applicable medical record review, for each participant.
Timepoint [18] 397606 0
At the conclusion of the study
Secondary outcome [19] 397607 0
Determination of duration of cervical spine immobilisation.

Duration will be determined by information provided by the initial treating clinician, and if applicable medical record review, for each participant.
Timepoint [19] 397607 0
At the conclusion of the study
Secondary outcome [20] 397608 0
Frequency of Adverse events associated with cervical spine imaging

The presence of adverse events will be determined by medical record review of each participant.
Timepoint [20] 397608 0
At the conclusion of the study
Secondary outcome [21] 397609 0
Inter-observer reliability of clinical decision rules (CDRs) - kappa coefficient
Timepoint [21] 397609 0
At the conclusion of the study
Secondary outcome [22] 397610 0
Cost effectiveness of implementing each CDR; health care costs of different imaging sequences.

Health care costs will be calculated from SONIC study data obtained from the medical record, hospital cost estimates of care provided (e.g. imaging costs, ED presentation) and estimates from the published literature of longer term outcomes (e.g. quality of life/utility values of participants with serious injury; epidemiological studies of risk of cancer resulting from imaging radiation exposure).
Timepoint [22] 397610 0
At the conclusion of the study

Eligibility
Key inclusion criteria
Children aged less than 16 years with possible cervical spine injury (CSI) after known or suspected blunt trauma
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who received cervical spine imaging at a centre not participating in this study prior to transfer with definitive external radiology reporting available at the time of arrival at the study ED will be excluded from accuracy analysis.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data analysis for primary and secondary outcomes will be performed once all data have been collected with no plan for an interim analysis.

The entire data set will be used to externally assess accuracy in identifying CSI using PECARN risk criteria in children or the adult- focussed CDRs with exact binomial 95% CIs. When applying each CDR, items will be scored as present, absent or unknown. Sensitivity, specificity, NPV and PPV of each of the CDRs will be calculated.

Accuracy of each rule will also be calculated using the exact inclusion, exclusion, predictor and outcome variables, and definitions as set out in the original publications.

An exploratory analysis of the data will be conducted to determine whether a new paediatric SONIC CDR can be derived and validated to improve the accuracy of CSI detection and/or improve risk stratification of children who do and do not require imaging.

Inter-observer reliability of CDR variables will be assessed on approximately five percent of patients at 2 sites.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2021
Actual
7/09/2021
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30000
Accrual to date
631
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC
Recruitment hospital [1] 19269 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 19270 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 19271 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 19272 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [5] 19273 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 19274 0
Perth Children's Hospital - Nedlands
Recruitment hospital [7] 19275 0
Monash Children’s Hospital - Clayton
Recruitment hospital [8] 19276 0
Sydney Children's Hospital - Randwick
Recruitment hospital [9] 19277 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 19278 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 19279 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 33850 0
3052 - Parkville
Recruitment postcode(s) [2] 33851 0
4101 - South Brisbane
Recruitment postcode(s) [3] 33852 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 33853 0
5006 - North Adelaide
Recruitment postcode(s) [5] 33854 0
2145 - Westmead
Recruitment postcode(s) [6] 33855 0
6009 - Nedlands
Recruitment postcode(s) [7] 33856 0
3168 - Clayton
Recruitment postcode(s) [8] 33857 0
2031 - Randwick
Recruitment postcode(s) [9] 33858 0
4215 - Southport
Recruitment postcode(s) [10] 33859 0
4575 - Birtinya
Recruitment postcode(s) [11] 33860 0
0810 - Tiwi
Recruitment outside Australia
Country [1] 23671 0
New Zealand
State/province [1] 23671 0
Auckland

Funding & Sponsors
Funding source category [1] 308501 0
Government body
Name [1] 308501 0
Australian Federal Government Department of Health
Country [1] 308501 0
Australia
Funding source category [2] 308505 0
Charities/Societies/Foundations
Name [2] 308505 0
Emergency Medicine Foundation
Country [2] 308505 0
Australia
Funding source category [3] 308506 0
Government body
Name [3] 308506 0
WA Department of Health
Country [3] 308506 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital
Flemington Road,
Parkville Victoria 3052
Australia
Country
Australia
Secondary sponsor category [1] 309357 0
None
Name [1] 309357 0
Address [1] 309357 0
Country [1] 309357 0
Other collaborator category [1] 281767 0
Hospital
Name [1] 281767 0
Cabrini Hospital
Address [1] 281767 0
181-183 Wattletree Rd,
Malvern VIC 3144 Australia
Country [1] 281767 0
Australia
Other collaborator category [2] 281768 0
University
Name [2] 281768 0
Queensland University of Technology
Address [2] 281768 0
Level 4/88 Musk Avenue
Kelvin Grove QLD 4059 Australia
Country [2] 281768 0
Australia
Other collaborator category [3] 281769 0
University
Name [3] 281769 0
Monash University
Address [3] 281769 0
Wellington Rd,
Clayton VIC 3800
Country [3] 281769 0
Australia
Other collaborator category [4] 281770 0
Other Collaborative groups
Name [4] 281770 0
Research Institute at Nationwide Children's Hospital
Address [4] 281770 0
700 Children's Dr, Columbus,
OH 43205, United States
Country [4] 281770 0
United States of America
Other collaborator category [5] 281771 0
University
Name [5] 281771 0
University of California
Address [5] 281771 0
1 Shields Ave,
Davis, CA 95616, USA
Country [5] 281771 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308462 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 308462 0
Ethics committee country [1] 308462 0
Australia
Date submitted for ethics approval [1] 308462 0
07/12/2020
Approval date [1] 308462 0
09/04/2021
Ethics approval number [1] 308462 0
69436

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110770 0
Prof Franz Babl
Address 110770 0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville, Victoria, 3052
Country 110770 0
Australia
Phone 110770 0
+61 399366748
Fax 110770 0
Email 110770 0
[email protected]
Contact person for public queries
Name 110771 0
Sharon O'Brien
Address 110771 0
C/- Emergency Department
Hospital Avenue
Nedlands Western Australia 6009
Country 110771 0
Australia
Phone 110771 0
+61 8 6456 4989
Fax 110771 0
Email 110771 0
[email protected]
Contact person for scientific queries
Name 110772 0
Natalie Phillips
Address 110772 0
Emergency Department
Queensland Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101
Country 110772 0
Australia
Phone 110772 0
+61 7 3068 4500
Fax 110772 0
Email 110772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The study team and sponsor will endeavour to make the published de-identified participant data available for use within the broader scientific community.
When will data be available (start and end dates)?
12 months after study completion and publication of the primary papers.
Available to whom?
Recognised clinical researchers
Available for what types of analyses?
Metanalysis
How or where can data be obtained?
Individuals or organisations seeking access to the de-identified data arising from the SONIC study can contact the study team, via Dr Natalie Phillips ([email protected]) or Professor Franz Babl ([email protected]). The request will be reviewed, taking into consideration scientific merit of the proposed use of the data, and legal, regulatory and ethical issues.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.