Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
09 04 2021
Historique:
entrez: 10 4 2021
pubmed: 11 4 2021
medline: 20 5 2021
Statut: epublish

Résumé

The 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. Early 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 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). ACTRN12619001422112.

Identifiants

pubmed: 33837094
pii: bmjopen-2020-041695
doi: 10.1136/bmjopen-2020-041695
pmc: PMC8043010
doi:

Substances chimiques

Biomarkers 0

Banques de données

ANZCTR
['ACTRN12619001422112']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e041695

Investigateurs

Jane Valentine (J)
Alison Salt (A)
Desiree Silva (D)
Caroline Alexander (C)
Natasha Amery (N)
Arlette Coenen (A)
Rose Morie (R)
Jennifer Moore (J)
Madeleine OConnor (M)
Ravisha Srinivasjois (R)
Jason Tan (J)
Brad Jongeling (B)
Elayne Downie (E)
Ruth Last (R)
Mary Sharp (M)
John Wray (J)
Sue-Anne Davidson (SA)
Ashleigh Thornton (A)

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Catherine Elliott (C)

Curtin University, Perth, Western Australia, Australia.
Telethon Kids Institute, Nedlands, West Australia, Australia.

Caroline Alexander (C)

Curtin University, Perth, Western Australia, Australia.

Alison Salt (A)

Perth Children's Hospital, Perth, Western Australia, Australia.

Alicia J Spittle (AJ)

University of Melbourne, Melbourne, Victoria, Australia.

Roslyn N Boyd (RN)

The University of Queensland, Brisbane, Queensland, Australia.

Nadia Badawi (N)

Cerebral Palsy Alliance Research Institute, Sydney, New South Wales, Australia.
Grace Centre for Newborn Intestive Care, The Childrens Hospital at Westmead, Sydney, New South Wales, Australia.
University of Sydney, Sydney, New South Wales, Australia.

Catherine Morgan (C)

Cerebral Palsy Alliance Research Institute, Sydney, New South Wales, Australia.
University of Sydney, Sydney, New South Wales, Australia.

Desiree Silva (D)

University of Western Australia, Perth, Western Australia, Australia.

Elizabeth Geelhoed (E)

University of Western Australia, Perth, Western Australia, Australia.

Robert S Ware (RS)

Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.

Alishum Ali (A)

Curtin University, Perth, Western Australia, Australia.

Anne McKenzie (A)

University of Western Australia, Perth, Western Australia, Australia.

David Bloom (D)

Harvard University, Cambridge, Massachusetts, USA.

Mary Sharp (M)

University of Western Australia, Perth, Western Australia, Australia.

Roslyn Ward (R)

Curtin University, Perth, Western Australia, Australia.
University of Notre Dame, Perth, WA, Australia.

Samudragupta Bora (S)

The University of Queensland, Brisbane, Queensland, Australia.
Mothers, Babies and Women's Health Program, Mater Research Institute, Brisbane, Queensland, Australia.

Susan Prescott (S)

University of Western Australia, Perth, Western Australia, Australia.

Susan Woolfenden (S)

University of New South Wales, Kensington, New South Wales, Australia.

Vuong Le (V)

Deakin University, Geelong, Victoria, Australia.

Sue-Anne Davidson (SA)

Perth Children's Hospital, Perth, Western Australia, Australia.

Ashleigh Thornton (A)

Perth Children's Hospital, Perth, Western Australia, Australia.
University of Western Australia, Perth, Western Autralian, Australia.

Amy Finlay-Jones (A)

Curtin University, Perth, Western Australia, Australia.
Telethon Kids Institute, Nedlands, West Australia, Australia.

Lynn Jensen (L)

Curtin University, Perth, Western Australia, Australia.

Natasha Amery (N)

Curtin University, Perth, Western Australia, Australia.

Jane Valentine (J)

Perth Children's Hospital, Perth, Western Australia, Australia jane.valentine@health.wa.gov.au.

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Classifications MeSH