ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619001422112

Ethics application status

Approved

Date submitted

2/10/2019

Date registered

15/10/2019

Date last updated

15/10/2019

Date data sharing statement initially provided

15/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Early Moves: Can babies' early movements predict cognitive impairment?

Scientific title

Early Moves: A cohort study to identify a very early biomarker of cognitive impairment

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive impairment

Neurodevelopmental disorders

Condition category

Condition code

Mental Health

Learning disabilities

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Observational cohort study of 3000 babies born at Joondalup Health Campus, WA to identify if General Movements (GMs) are an early biomarker for cognitive impairment. All babies will have two GM assessments by four months corrected age, and followed until two years, when a full cognitive assessment will be conducted.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

General Movements Assessment

Timepoint [1]

4 weeks and 12 weeks corrected age

Primary outcome [2]

Bayley Scale of Infant and Toddler Development - 4, Cognitive and Language Scores

Timepoint [2]

2 years corrected age

Secondary outcome [1]

Ages and Stages Questionnaire - Third Edition, Communication, Problem Solving and Personal-Social assessment areas

Timepoint [1]

2 years corrected age

Eligibility

Key inclusion criteria

Intended birth at Joondalup Health Campus between 2019 and 2023
Enrolled in The ORIGINS Project

Minimum age

No limit

Maximum age

3 Days

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Insufficient English to complete standard questionnaires
Baby is receiving intervention targeted at improving cognitive or language outcomes

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Sample Size: Recruitment of 3,000 babies is sufficient to establish a minimum 90% sensitivity and 94% specificity (alpha 0.05 and assuming actual sensitivity and specificity is 92.5% and 95%, 15% attrition, 15% non-readable images).
The primary outcome will be assessed using standard diagnostic statistics (e.g. sensitivity, specificity, predictive values, and likelihood ratios). The predictive validity of the GM categorical classification will be established using logistic regression.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/10/2019

Actual

Date of last participant enrolment

Anticipated

31/12/2022

Actual

Date of last data collection

Anticipated

31/12/2024

Actual

Sample size

Target

3000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Joondalup Health Campus - Joondalup

Recruitment postcode(s) [1]

6027 - Joondalup

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

CP Alliance

Address [1]

187 Allambie Road Allambie Heights NSW 2100

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Perth Children's Hospital Foundation

Address [2]

15 Hospital Ave, Nedlands, WA, 6009

Country [2]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent St
Bentley, WA, 6102

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Joondalup Health Campus

Address [1]

Grand Blvd & Shenton Ave, Joondalup, WA, 6027

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

Perth Children's Hospital

Address [1]

15 Hospital Ave, Nedlands, WA, 6009

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Joondalup Health Campus HREC

Ethics committee address [1]

Research Ethics Department
Joondalup Health Campus
Grand Blvd & Shenton Ave,
Joondalup, WA, 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2019

Approval date [1]

09/04/2019

Ethics approval number [1]

1902

Summary

Brief summary

 Early Moves aims to identify early biomarkers for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life. In the Early Moves study, parents will use a  smart-phone app called Baby Moves to video their babies General Movements (GMs), with automated scoring being developed through machine-learning. GMs are spontaneous movements of babies less than 3 months old and provide insight into the function of a baby’s brain. Infants in the study will be assessed cognitive impairment at age two years using a standardised test of toddler development. It is hypothesised that GMs are sufficiently predictive of cognitive impairment at two years to act as a reliable screening tool.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Catherine Elliott

Address

School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Kent St, Bentley, WA 6102

Country

Australia

Phone

+61 416246627

Fax

[email protected]

Contact person for public queries

Name

Caroline Alexander

Address

Perth Children's Hospital 15 Hospital Ave, Nedlands, WA 6009

Country

Australia

Phone

+61 864565070

Fax

[email protected]

Contact person for scientific queries

Name

Catherine Elliott

Address

School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Kent St, Bentley, WA 6102

Country

Australia

Phone

+61 416246627

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• On a case-by-case basis, at the discretion of the primary sponsor, to researchers who provide a methodologically sound proposal with appropriate research governance and ethics approvals

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified outcome data from the General Movement assessments and Bayley-4 assessments

What types of analyses could be done with individual participant data?

• For IPD-meta-analyses or to achieve only the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
Beginning 6 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by the principal investigator. Contact Professor Catherine Elliott at [email protected]

Are there extra considerations when requesting access to individual participant data?

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

Source	Title	Year of Publication	DOI
Embase	Early Moves: A Protocol for A Population-Based Prospective Cohort Study to Establish General Movements As An Early Biomarker of Cognitive Impairment in Infants.	2021	https://dx.doi.org/10.1136/bmjopen-2020-041695

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically