None listed
Conditions
Brief summary
In Australia, Cerebral Palsy is the most common childhood physical disability (1 in 700) resulting in a lifelong complex chronic disability. Historically CP was not confirmed until the second year of life, and as a result early neuroprotection and early intervention were not always provided. In the past 4 years our Australasian Cerebral Palsy Clinical Trials Network, has implemented early detection so that at risk infants have been recruited by equal or less than 6 months corrected age into Randomised Controlled Trials (RCTs) of Neuroprotectants and early Neurorehabilitation to determine if these interventions improve motor and cognitive outcomes at 2 years corrected age (CA) This study enables us to undertake longer term follow-up of school readiness at 4 years to 6 years 3 months CA (prior to commencing school) which is unknown.
Interventions
The present study is a 4 years to 6 years 3 months corrected age (CA) follow-up at one time point, combining 4 RCTs of infants recruited <6 months CA (1-4) or participated in other early-intervention studies (5). School readiness outcomes will be prepared to an historical cohort of children from the Australian CP Child study (6) who were diagnosed >2 years and received CAU:
(1) PROTECT Me (ACTRN12617001515381, n=275): 10mg melatonin versus placebo with CAU
(2) GAME (ACTRN12617000006347, n=300):
The present study is a 4 years to 6 years 3 months corrected age (CA) follow-up at one time point, combining 4 RCTs of infants recruited <6 months CA (1-4) or participated in other early-intervention studies (5). School readiness outcomes will be prepared to an historical cohort of children from the Australian CP Child study (6) who were diagnosed >2 years and received CAU: (1) PROTECT Me (ACTRN12617001515381, n=275): 10mg melatonin versus placebo with CAU (2) GAME (ACTRN12617000006347, n=300): Goal directed training in a motor enriched environment (i.e. novel neuroplasticity neurorehabilitation) versus CAU (3) REACH (ACTRN12615000180516, n=98): Baby mCIMT compared to an equal dose of Baby BIM (4) PACT (ACTRN12616000351415, n=66): online parenting course, using environmental enrichment through enhanced mother infant emotional availability (5) Preschool HABIT-ILE (ACTRN12620000071921, n=60): A randomised controlled trial to determine efficacy of intensive rehabilitation compared to usual care to improve motor skills of children aged 2-5 years, with bilateral cerebral palsy. (6) Australian CP-Child (ACTRN12612001269820, n=245): a prospective cohort study of motor development and brain structure in young children, with cerebral palsy born in Queensland in 2006, 2007, 2008 and 2009. Data will be collected in one of four ways: • Paper forms • Online survey platform (REDcap) instead of/in addition to paper forms for Parent Q’s. • Devices (ActiGraph, photo/video/audio recording devices) owned by sites/organisations (not personal devices) • Face-to-face assessments with the child
Sponsors
Queensland Cerebral Palsy and Rehabilitation Research, Faculty of Medicine, The University of Queensland
Eligibility
Sex/Gender
All
Age
48 Months to 75 Months
Healthy volunteers
No
Inclusion criteria
INCLUSION CRITERIA (a) Children diagnosed with CP or at high risk of CP based on their recruitment and follow-up in the REACH (ACTRN12615000180516), GAME (ACTRN12617000006347), EARLY PACT (ACTRN12616000351415), Protect Me (ACTRN12617001515381) and Preschool HABIT-ILE (ACTRN12620000071921) Clinical Trials; (b) aged > 2 yrs (between 4 years to 6 years and 3 months corrected age (CA) at the time of assessment); (c) able to attend testing sessions;
Exclusion criteria
None
Outcome results
None listed