Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants
,
Alicia J Spittle,
Robert S Ware,
Catherine Morgan,
Susan Woolfenden,
Natasha Amery,
Jason Tan,
Nadia Badawi,
Roslyn N Boyd,
Anne McKenzie,
Catherine Elliott,
Elizabeth Geelhoed,
Samudragupta Bora,
Mary Sharp,
Amy Finlay-Jones,
Caroline Alexander,
Alison Salt,
Desiree Silva,
Alishum Ali,
David Bloom,
Roslyn Ward,
Susan Prescott,
Vuong Le,
Sue-Anne Davidson,
Ashleigh Thornton,
Lynn Jensen,
Jane Valentine,
Arlette Coenen,
Rose Morie,
Jennifer Moore,
Madeleine OConnor,
Ravisha Srinivasjois,
Brad Jongeling,
Elayne Downie,
Ruth Last,
John Wray
Affiliations
3University College London
Alicia J Spittle
2 Victorian Infant Brain Studies, Murdoch Children`s Research Institute, Parkville, Victoria, Australia
Robert S Ware
Faculty of Health, Griffith University, Southport, Queensland, Australia
Catherine Morgan
The University of Auckland School of Psychology, Auckland, New Zealand
Susan Woolfenden
1 Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia
Natasha Amery
Curtin University, Perth, Western Australia, Australia
Jason Tan
Nadia Badawi
Cerebral Palsy Alliance, Sydney, New South Wales, Australia
Roslyn N Boyd
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Anne McKenzie
University of Western Australia, Perth, Western Australia, Australia
Catherine Elliott
School of Allied Health, Curtin University, Perth, Western Australia, Australia
Elizabeth Geelhoed
School of Population Health, The University of Western Australia, Perth, Western Australia, Australia
Samudragupta Bora
Department of Pediatrics, University Hospitals Rainbow Babies & Children`s Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Mary Sharp
2 School of Medicine, The University of Western Australia, Perth, Western Australia, Australia
Amy Finlay-Jones
Curtin University, Perth, Western Australia, Australia
Caroline Alexander
Curtin University, Perth, Western Australia, Australia
Alison Salt
Perth Children’s Hospital, Perth, Western Australia, Australia
Desiree Silva
University of Western Australia, Perth, Western Australia, Australia
Alishum Ali
Curtin University, Perth, Western Australia, Australia
David Bloom
Department of Global Health and Population, Harvard School of Public Health, Boston, Massachusetts, USA
Roslyn Ward
Curtin University, Perth, Western Australia, Australia
Susan Prescott
University of Western Australia, Perth, Western Australia, Australia
Vuong Le
Deakin University, Geelong, Victoria, Australia
Sue-Anne Davidson
Perth Children’s Hospital, Perth, Western Australia, Australia
Ashleigh Thornton
Perth Children’s Hospital, Perth, Western Australia, Australia
Lynn Jensen
Curtin University, Perth, Western Australia, Australia
Jane Valentine
Telethon Kids Institute, Perth, Western Australia, Australia
Introduction 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.Method and analysis 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 and dissemination 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).Trial registration number ACTRN12619001422112.
