Trial from ANZCTR


Trial ID ACTRN12612001269820
Trial Status: Registered
Date Submitted: 4/12/2012
Date Registered: 4/12/2012
Retrospectively registered

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Public title Australian Cerebral Palsy Child: a prospective cohort study of motor development and brain structure in young children with cerebral palsy.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Australian Cerebral Palsy Child- 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.
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Secondary ID [1] 281579 0
Nil
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UTN
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Trial acronym CPchild
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Health condition(s) or problem(s) studied:
cerebral palsy 287861 0
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Condition category: Condition code:
Musculoskeletal Other muscular and skeletal disorders
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288220 288220 0 0
Neurological Other neurological disorders
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288266 288266 0 0

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Descriptions of intervention(s) / exposure Longitudinal measurement of Gross Motor Function (GMFM 66), Gross motor function classification, motor type, distribution(bilateral, unilateral), brain structure (location, extent, presumed timing of lesion), classification of comorbidities(epilepsy,vision,hearing,health status), musculoskeletal development, participation and relationship between motor prognosis and resource use at 18 months, 2 years, 30 months, 3 years, 4 years and 5 years corrected age.
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Intervention Code:
Not applicable - Observational study 286102 0
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Comparator / control treatment Comparisons will be made between children in the different Gross Motor Function Classification System (GMFCS) categories.
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Control group Uncontrolled
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Primary Outcome: Longitudinal measurement of Gross Motor Function (GMFM 66) 288416 0
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age 288416 0
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Primary Outcome: Classification of brain injury by Magnetic Resonance Imaging (MRI).
The brain will be classified by the anatomical features of the lesion, the presumed aetiology and the presumed timing of the insult that caused the lesion.
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Timepoint: MRI from 2 years 288417 0
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Secondary Outcome: Gross motor function classification status(GMFCS I-V), 300101 0
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age 300101 0
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Secondary Outcome: Motor type Motor type (spastic, dystonic, hypotonic and distibution (unilateral, bialteral and number of limbs involved) will be classified according to
the Surveillance of Cerbral Palsy in Europe guidelines and the North American Task Force on Childhood Motor Disorders
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age 300137 0
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Secondary Outcome: Clinical history and examination by medical personnel at study entry
Classification of co-morbidities: epilepsy, vision, hearing and health status
300138 0
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Timepoint: at time of entry to the study, may be at either 18 months, 2 years , or at 30 months, 3 years, 4 years or 5 years. 300138 0
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Secondary Outcome: Hip displacement:
Hip displacement will be assessed by 6 monthly pelvic radiographs with radiological measures migration percentage (MP), acetabular index (AI), Hilgenreiners Epiphyseal angle
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years. 300139 0
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Secondary Outcome: Resource use and direct costs of treatment:
In order to determine the relationship between motor prognosis and resource use, medical resource use and the direct costs of treatment will be monitored and compared to outcomes with adjustment for confounders such as disease severity using cost and consequence analysis.
300140 0
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years 300140 0
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Secondary Outcome: Upper limb function.
The Manual Assessment Clsssification System will be used to classify hand function based on the child's typical performance when handling objects in daily activities.
300141 0
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years 300141 0
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Secondary Outcome: Communication difficulties by parent self-report on the Communication and Symbolic Behaviour Scales-Development Profile (CSBS-DP) 300176 0
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Timepoint: 18 months, 2 years, 30 months, 3 years, 4 years and 5 years 300176 0
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Key inclusion criteria All children diagnosed with cerebral palsy, born in Victoria between 1 January 2004 and 31 December 2005; and in Queensland between 1 January 2006 and 31 December 2009.
We define cerebral palsy a a group of permanent disorders of movement and posture that attributed to non-progressive disturbances that occurred in the developing foetal or infant brain. The characteristic signs are spasticity, movement disorders, muscle weakness, ataxia and rigidity.
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Minimum age 18 Months
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Maximum age 5 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Children with a progressive or neurodegenerative lesion will be excluded from the study.
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Study type Observational
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Patient registry
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Target follow-up duration  
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Purpose Natural history
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Duration Longitudinal
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Selection Defined population
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Timing Prospective
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 3/08/2005
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 240
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 286397 0
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Name: National Health and Medical Research Council 286397 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
286397 0
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Country: Australia 286397 0
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Funding Source: Charities/Societies/Foundations 286398 0
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Name: Telstra Community Development Fund 286398 0
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Address: Telstra Foundation
Post Locked Bag 5680
Melbourne
Vic 3001
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Country: Australia 286398 0
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Funding Source: Other Collaborative groups 286399 0
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Name: Murdoch Childrens Research Institute 286399 0
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Address: Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville
Vic 3052
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Country: Australia 286399 0
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Primary Sponsor Individual
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Name: Professor Roslyn Boyd
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Address: Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 7 Block 6
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
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Country: Australia
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Secondary Sponsor: Individual 285198 0
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Name: A/Prof Michael Fahey 285198 0
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Address: Monash Medical Centre
246 Clayton Rd
Clayton
Victoria 3168
285198 0
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Country: Australia 285198 0
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Secondary Sponsor: Individual 285199 0
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Name: A/Prof Barry Rawicki 285199 0
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Address: Monash Medical Centre
246 Clayton Rd
Clayton
Victoria 3168
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Country: Australia 285199 0
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Other Collaborator: Hospital 277206 0
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Name: Royal Children's Hospital 277206 0
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Address: Royal Children's Hospital
Herston Rd
Herston
Queensland 4029
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Country: Australia 277206 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The Royal Children's Hospital, Melbourne 288469 0
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Address: Royal Children's Hospital Ethics Committee
Flemington Rd
Parkville
Victoria 3052
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Country: Australia 288469 0
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Approval Date: 22/12/2006 288469 0
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Submitted Date: 288469 0
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HREC: 25010F 288469 0
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Ethics Committee name: Southern Health Ethics Committee C 288480 0
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Address: Southern Health
246 Clayton Rd
Clayton Vic 3168
288480 0
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Country: Australia 288480 0
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Approval Date: 07/09/2005 288480 0
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Submitted Date: 288480 0
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HREC: 05077C 288480 0
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Ethics Committee name: Queensland Children's Health Services(RCH) Human Research Ethics Committee 288481 0
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Address: Royal Children's Hospital-Human Research Ethics Committee
Level 3 Foundation Building
Department of Paediatrics and Child Health
Herston Rd
Herston
Queensland 4029
288481 0
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Country: Australia 288481 0
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Approval Date: 31/10/2007 288481 0
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Submitted Date: 288481 0
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HREC: HREC/07QRCH/107 288481 0
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Ethics Committee name: Mater Health Services 288496 0
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Address: Mater Health Services Human Research Ethics Committee
Raymond Tce
South Brisbane
Qld 4101
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Country: Australia 288496 0
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Approval Date: 14/07/2008 288496 0
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Submitted Date: 288496 0
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HREC: 1186C 288496 0
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Brief summary This prospective, population based longitudinal study of children, with cerebral palsy, aged 18 months to 5 years will track early motor development and will utilise magnetic resonance imaging to determine the anatomical pattern and likely aetiology and timing of the brain lesion. This will help predict the likely need for, type and timing of interventions(spasticity management, rehabilitation, orthopaedic surgery) and their associated costs, this study will enable more informed resource planning for cerebral palsy in young children for the future.
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Trial website https://www.som.uq.edu.au/research/research-centres/cerebral-palsy-and-rehabilitation-research-centre/our-research/qld-cpchild.aspx
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Professor Roslyn Boyd
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Address: Queensland Cerebral Palasy and Rehabilitation Research Centre Level 7 Block 6 Royal Brisbane and Women's Hospital Butterfield St Herston QLD 4029
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Country: Australia
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Tel: +61 7 3365 5315
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Email: r.boyd@uq.edu.au
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Contact person for scientific queries
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Name: Professor Roslyn Boyd
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Address: Queensland Cerebral Palsy and Rehabilitation Research Centre Level 7 Block 6 Royal Brisbane and Women's Hospital Butterfield St Herston QLD 4029
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Country: Australia
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Tel: +61 7 3365 5315
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Email: r.boyd@uq.edu.au
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Contact person responsible for updating information
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Name: Laura Pareezer
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Address: Queensland Cerebral Palasy and Rehabilitation Research Centre Level 7 Block 6 Royal Brisbane and Women's Hospital Butterfield St Herston QLD 4029
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Country: Australia
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Tel: +61 7 3646 5061
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Email: Laura.Pareezer@uq.edu.au
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Addition Cancer fields
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