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Early Moves: A Protocol for A Population-Based Prospective Cohort Study to Establish General Movements As An Early Biomarker of Cognitive Impairment in Infants

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Version 3 2024-06-19, 02:30
Version 2 2024-06-06, 08:40
Version 1 2021-04-22, 08:24
journal contribution
posted on 2024-06-19, 02:30 authored by C Elliott, C Alexander, A Salt, AJ Spittle, RN Boyd, N Badawi, C Morgan, D Silva, E Geelhoed, RS Ware, A Ali, A McKenzie, D Bloom, M Sharp, R Ward, S Bora, S Prescott, S Woolfenden, V Le, SA Davidson, A Thornton, A Finlay-Jones, L Jensen, N Amery, J Valentine
IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), 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.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

History

Journal

BMJ Open

Volume

11

Article number

ARTN e041695

Pagination

1 - 9

Location

England

Open access

  • Yes

ISSN

2044-6055

eISSN

2044-6055

Language

English

Publication classification

C1 Refereed article in a scholarly journal

Issue

4

Publisher

BMJ PUBLISHING GROUP