School readiness of children at high risk of cerebral palsy randomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials
Robert S Ware,
Catherine Morgan,
Nadia Badawi,
Jane Wotherspoon,
Koa Whittingham,
Roslyn N Boyd,
Stewart Trost,
Leanne Sakzewski,
Sarah Mcintyre,
Hayley Smithers Sheedy,
Iona Novak,
Kerstin Pannek,
Tracy Comans,
Andrea Burgess,
Samudragupta Bora,
Kristie Bell,
Katherine Benfer,
Syed Afroz Keramat,
Michael Collingwood Fahey,
Alex Pagnozzi,
Kirsten Rebecca Palmer,
Ashleigh Hines,
Laura Gascoigne-Pees,
Shaneen Leishman,
Stina Oftedal
Affiliations
Robert S Ware
Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia
Catherine Morgan
1 Pediatrics, University of Alberta, Edmonton, Alberta, Canada
Nadia Badawi
9 Grace Centre for Newborn Intensive Care, Children’s Hosital at Westmead, Sydney, New South Wales, Australia
Jane Wotherspoon
1 Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia
Koa Whittingham
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, 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
Stewart Trost
School of Human Movement and Nutrition Sciences, The University of Queensland, Saint Lucia, Queensland, Australia
Leanne Sakzewski
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Sarah Mcintyre
9 Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney Medical School, Sydney, New South Wales, Australia
Hayley Smithers Sheedy
Cerebral Palsy Alliance Research Institute, Specialty of Child & Adolescent Health, Sydney Medical School, Faculty of Medicine & Health, The University of Sydney, Sydney, New South Wales, Australia
Iona Novak
3 Cerebral Palsy Alliance, Brookvale, New South Wales, Australia
Kerstin Pannek
11 Health and Biosecurity, The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia
Tracy Comans
Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia
Andrea Burgess
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Samudragupta Bora
Department of Pediatrics, University Hospitals Rainbow Babies & Children`s Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
Kristie Bell
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Katherine Benfer
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia
Syed Afroz Keramat
Child Health Research Centre, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, Australia
Michael Collingwood Fahey
Paediatrics, Monash University, Clayton, Victoria, Australia
Alex Pagnozzi
The Australian e-Health Research Centre, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Canberra, Australian Capital Territory, Australia
Kirsten Rebecca Palmer
Obstetrics and Gynaecology, Monash University School of Clinical Sciences at Monash Health, Clayton, Victoria, Australia
Ashleigh Hines
Cerebral Palsy Alliance Research Institute, Specialty of Child & Adolescent Health, Sydney Medical School, Faculty of Medicine & Health, The University of Sydney, Sydney, New South Wales, Australia
Laura Gascoigne-Pees
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Shaneen Leishman
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Stina Oftedal
Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
Introduction School readiness includes cognitive, socio-emotional, language and physical growth and development domains which share strong associations with life-course opportunities. Children with cerebral palsy (CP) are at increased risk of poor school readiness compared with their typically developing peers. Recently, earlier diagnosis of CP has allowed interventions to commence sooner, harnessing neuroplasticity. First, we hypothesise that early referral to intervention for children at-risk of CP will lead to improved school readiness at 4–6 years relative to placebo or care as usual. Second, we hypothesise that receipt of early diagnosis and early intervention will lead to cost-savings in the form of reduced healthcare utilisation.Methods and analysis Infants identified as at-risk of CP ≤6 months corrected age (n=425) recruited to four randomised trials of neuroprotectants (n=1), early neurorehabilitation (n=2) or early parenting support (n=1) will be re-recruited to one overarching follow-up study at age 4–6 years 3 months. A comprehensive battery of standardised assessments and questionnaires will be administered to assess all domains of school readiness and associated risk factors. Participants will be compared with a historical control group of children (n=245) who were diagnosed with CP in their second year of life. Mixed-effects regression models will be used to compare school readiness outcomes between those referred for early intervention versus placebo/care-as-usual. We will also compare health-resource use associated with early diagnosis and intervention versus later diagnosis and intervention.Ethics and dissemination The Children’s Health Queensland Hospital and Health Service, The University of Queensland, University of Sydney, Monash University and Curtin University Human Research Ethics Committees have approved this study. Informed consent will be sought from the parent or legal guardian of every child invited to participate. Results will be disseminated in peer-reviewed journals, scientific conferences and professional organisations, and to people with lived experience of CP and their families.Trial registration number ACTRN12621001253897.
