ANZCTR - Registration

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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]

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

Condition category

Condition code

Emergency medicine

Other emergency care

Injuries and Accidents

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]

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]

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]

At the conclusion of the study

Primary outcome [2]

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]

At the conclusion of the study

Primary outcome [3]

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]

At the conclusion of the study

Secondary outcome [1]

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]

At the conclusion of study

Secondary outcome [2]

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]

At the conclusion of study

Secondary outcome [3]

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]

At the conclusion of study

Secondary outcome [4]

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]

At the conclusion of study

Secondary outcome [5]

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]

At the conclusion of study

Secondary outcome [6]

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]

At the conclusion of study

Secondary outcome [7]

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]

At the conclusion of study

Secondary outcome [8]

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]

At the conclusion of study

Secondary outcome [9]

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]

At the conclusion of study

Secondary outcome [10]

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]

At the conclusion of the study

Secondary outcome [11]

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]

At the conclusion of the study

Secondary outcome [12]

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]

At the conclusion of the study

Secondary outcome [13]

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]

At the conclusion of the study

Secondary outcome [14]

Rate of surgical intervention of the cervical spine (as determined by clinical record review)

Timepoint [14]

At the conclusion of the study

Secondary outcome [15]

Determination of missed injury rate, if any, with x-ray (XR)

Timepoint [15]

At the conclusion of the study

Secondary outcome [16]

Determination of missed injury rate, if any, with computed tomography (CT)

Timepoint [16]

At the conclusion of the study

Secondary outcome [17]

Determination of missed injury rate, if any, with magnetic resonance imaging (MRI).

Timepoint [17]

At the conclusion of the study

Secondary outcome [18]

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]

At the conclusion of the study

Secondary outcome [19]

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]

At the conclusion of the study

Secondary outcome [20]

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]

At the conclusion of the study

Secondary outcome [21]

Inter-observer reliability of clinical decision rules (CDRs) - kappa coefficient

Timepoint [21]

At the conclusion of the study

Secondary outcome [22]

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]

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?

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]

The Royal Childrens Hospital - Parkville

Recruitment hospital [2]

Queensland Children's Hospital - South Brisbane

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment hospital [4]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [5]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [6]

Perth Children's Hospital - Nedlands

Recruitment hospital [7]

Monash Children’s Hospital - Clayton

Recruitment hospital [8]

Sydney Children's Hospital - Randwick

Recruitment hospital [9]

Gold Coast University Hospital - Southport

Recruitment hospital [10]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [11]

Royal Darwin Hospital - Tiwi

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment postcode(s) [3]

4131 - Meadowbrook

Recruitment postcode(s) [4]

5006 - North Adelaide

Recruitment postcode(s) [5]

2145 - Westmead

Recruitment postcode(s) [6]

6009 - Nedlands

Recruitment postcode(s) [7]

3168 - Clayton

Recruitment postcode(s) [8]

2031 - Randwick

Recruitment postcode(s) [9]

4215 - Southport

Recruitment postcode(s) [10]

4575 - Birtinya

Recruitment postcode(s) [11]

0810 - Tiwi

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Federal Government Department of Health

Address [1]

Department of Health
GPO Box 9848
Canberra ACT 2601
Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Emergency Medicine Foundation

Address [2]

Suite 1B, Terraces,
19 Lang Parade,
Milton Qld 4064

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

WA Department of Health

Address [3]

Research Development Unit
Department of Health
PO Box 8172
Perth Business Centre
PERTH WA 6849

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Cabrini Hospital

Address [1]

181-183 Wattletree Rd,
Malvern VIC 3144 Australia

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Queensland University of Technology

Address [2]

Level 4/88 Musk Avenue
Kelvin Grove QLD 4059 Australia

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Monash University

Address [3]

Wellington Rd,
Clayton VIC 3800

Country [3]

Australia

Other collaborator category [4]

Other Collaborative groups

Name [4]

Research Institute at Nationwide Children's Hospital

Address [4]

700 Children's Dr, Columbus,
OH 43205, United States

Country [4]

United States of America

Other collaborator category [5]

University

Name [5]

University of California

Address [5]

1 Shields Ave,
Davis, CA 95616, USA

Country [5]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children’s Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance
The Royal Children’s Hospital Melbourne
55 Flemington Road
Parkville 3052 VIC
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2020

Approval date [1]

09/04/2021

Ethics approval number [1]

69436

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

New Zealand sites (2):
Starship Children's Hospital, Auckland
Kidz First Hospital, Auckland

Contacts

Principal investigator

Name

Prof Franz Babl

Address

Emergency Department
Royal Children's Hospital
Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+61 399366748

Fax

[email protected]

Contact person for public queries

Name

Ms Sharon O'Brien

Address

C/- Emergency Department
Hospital Avenue
Nedlands Western Australia 6009

Country

Australia

Phone

+61 8 6456 4989

Fax

[email protected]

Contact person for scientific queries

Name

Dr Natalie Phillips

Address

Emergency Department
Queensland Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 3068 4500

Fax

[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.

Trial Review

Documents added manually

Documents added automatically