Trial Review

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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] 298926 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 313918 0
Neurodevelopmental disorders 313919 0
Condition category
Condition code
Mental Health 312327 312327 0 0
Learning disabilities
Neurological 313088 313088 0 0
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] 315208 0
Early Detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320958 0
General Movements Assessment
Timepoint [1] 320958 0
4 weeks and 12 weeks corrected age
Primary outcome [2] 321631 0
Bayley Scale of Infant and Toddler Development - 4, Cognitive and Language Scores
Timepoint [2] 321631 0
2 years corrected age
Secondary outcome [1] 373533 0
Ages and Stages Questionnaire - Third Edition, Communication, Problem Solving and Personal-Social assessment areas
Timepoint [1] 373533 0
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)
WA
Recruitment hospital [1] 14436 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 27449 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 303471 0
Charities/Societies/Foundations
Name [1] 303471 0
CP Alliance
Country [1] 303471 0
Australia
Funding source category [2] 303486 0
Charities/Societies/Foundations
Name [2] 303486 0
Perth Children's Hospital Foundation
Country [2] 303486 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley, WA, 6102
Country
Australia
Secondary sponsor category [1] 303546 0
Hospital
Name [1] 303546 0
Joondalup Health Campus
Address [1] 303546 0
Grand Blvd & Shenton Ave,
Joondalup, WA, 6027
Country [1] 303546 0
Australia
Other collaborator category [1] 280945 0
Hospital
Name [1] 280945 0
Perth Children's Hospital
Address [1] 280945 0
15 Hospital Ave,
Nedlands, WA, 6009
Country [1] 280945 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304001 0
Joondalup Health Campus HREC
Ethics committee address [1] 304001 0
Ethics committee country [1] 304001 0
Australia
Date submitted for ethics approval [1] 304001 0
29/01/2019
Approval date [1] 304001 0
09/04/2019
Ethics approval number [1] 304001 0
1902

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

Contacts
Principal investigator
Name 95514 0
Prof Catherine Elliott
Address 95514 0
School of Occupational Therapy, Social Work and Speech Pathology,
Curtin University,
Kent St,
Bentley, WA 6102
Country 95514 0
Australia
Phone 95514 0
+61 416246627
Fax 95514 0
Email 95514 0
[email protected]
Contact person for public queries
Name 95515 0
Caroline Alexander
Address 95515 0
Perth Children's Hospital
15 Hospital Ave,
Nedlands, WA 6009
Country 95515 0
Australia
Phone 95515 0
+61 864565070
Fax 95515 0
Email 95515 0
[email protected]
Contact person for scientific queries
Name 95516 0
Catherine Elliott
Address 95516 0
School of Occupational Therapy, Social Work and Speech Pathology,
Curtin University,
Kent St,
Bentley, WA 6102
Country 95516 0
Australia
Phone 95516 0
+61 416246627
Fax 95516 0
Email 95516 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?
De-identified outcome data from the General Movement assessments and Bayley-4 assessments
When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following main results publication
Available to whom?
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
Available for what types of analyses?
For IPD-meta-analyses or to achieve only the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by the principal investigator. Contact Professor Catherine Elliott at [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseEarly Moves: A Protocol for A Population-Based Prospective Cohort Study to Establish General Movements As An Early Biomarker of Cognitive Impairment in Infants.2021https://dx.doi.org/10.1136/bmjopen-2020-041695
N.B. These documents automatically identified may not have been verified by the study sponsor.