Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001488493
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
26/10/2016
Date last updated
28/10/2021
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
PREDICT CP: Implementation of comprehensive surveillance to Predict outcomes for school aged children with Cerebral Palsy
Scientific title
PREDICT CP: Implementation of comprehensive surveillance to Predict outcomes for school aged children with Cerebral Palsy
Secondary ID [1] 290365 0
Nil known
Universal Trial Number (UTN)
U1111-1188-9043
Trial acronym
PREDICT CP
Linked study record
ACTRN 1261200169820

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 300654 0
Condition category
Condition code
Musculoskeletal 300504 300504 0 0
Other muscular and skeletal disorders
Neurological 300505 300505 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 300506 300506 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study undertakes comprehensive surveillance of children, aged between 8 to 12 years (born in the birth years 2006-2011) with Cerebral Palsy.These children were either examined from 2 to 5 years as part of two previous overlapping, longitudinal studies (NHMRC 465128; NHMRC 569605, ACTRN 1261200169820) or are registered with the Queensland Paediatric Rehabilitation Service (QPRS) . The participants may be observed at any time during the four year period, depending on their availability. Due to the nature of the study, which includes a 3Tmagnetic resonance imaging (MRI) brain scan and a number of clinical assessments, the children will ideally be seen once over 1.5 days
Intervention code [1] 296177 0
Not applicable
Comparator / control treatment
Children invited to participate in Predict-CP have either taken part in two previous overlapping, prospective, longitudinal Cerebral Palsy cohort studies (ACTRN 1261200169820, NHMRC 465128; NHMRC 569605), between 1.5 to 5 years of age, or are registered with the Queensland Paediatric Rehabilitation Service (QPRCS). This data was collected between January 2006 and December 2014 by our research group at the University of Queensland.

We will now be re-evaluating relationships between brain structure at 3T, health care utilisation, functional- and social-outcomes of the same participant cohort at 8-12 years.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299932 0
Composite Outcome: The location, extent of the brain lesion(s) on semi-quantitative on 3T MRI and motor capacity on Gross Motor Function Measure (GMFM-66) at 8-12 years
Timepoint [1] 299932 0
The assessments will occur as children in the three birth years reach 8 years of age.
Primary outcome [2] 299933 0
2. . The attainment of fine motor development on the Assisting Hand Assessment (AHA) or Both Hands Assessment (BoHA).
Timepoint [2] 299933 0
The assessments will occur as children in the three birth years reach 8 years of age.
Primary outcome [3] 299934 0
3. Communication on the Clinical Evaluation of language fundamentals screener (CELF-4) and the Peabody Picture vocabulary test.
Timepoint [3] 299934 0
The assessments will occur as children in the three birth years reach 8 years of age.
Secondary outcome [1] 328579 0
Composite Secondary outcome: Nutritional status (under/overweight) and oropharyngeal swallowing function will be determined by food record and video-taped feeding assessment.
Timepoint [1] 328579 0
The assessments will occur as children in the three birth years reach 8 years of age.
Secondary outcome [2] 328602 0
Composite Secondary Outcome: Cognition and executive function will be assessed using the Ravens Coloured progressive matrices and the Behaviour rating Inventory of Executive Function (BRIEF).
Timepoint [2] 328602 0
The assessments will occur as children in the three birth years reach 8 years of age.

Eligibility
Key inclusion criteria
All children diagnosed with CP, born between 1st January 2006 and 31st December, 2011 in Queensland that have either participated in the CPChild study (ACTRN 1261200169820), a prospective longitudinal cohort study between the ages of 1.5 to 5 years, or who are registered with the Queensland Paediatric Rehabilitation service (QPRS) will now be invited to return at 8-12 years. For inclusion criteria Cerebral Palsy is defined as a permanent (but not unchanging) disorder of movement and posture that results from an insult to the developing central nervous system. The characteristic signs are spasticity, movement disorders, muscle weakness, ataxia and rigidity.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children with a progressive or neurodegenerative lesion.
2. Children born outside Queensland in the relevant birth years.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A comprehensive database has been established for all data collection, including clinical measures, MRI scoring and questionnaires so that it is entered prospectively at the time of each assessment. Summary reports are automatically generated from the database to report back to families and treating clinicians after each visit. Our biostatistician will supervise the statistical methods proposed in this study, including analysis of binary outcomes in longitudinal studies using weighted estimating equations (e.g. presence of co morbidities); multilevel mixed-effects models of longitudinal binary outcomes (e.g. GMFCS levels), and generalised estimating equations for ordinal data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
1/11/2016
Date of last participant enrolment
Anticipated
31/10/2020
Actual
31/12/2020
Date of last data collection
Anticipated
31/10/2020
Actual
31/12/2020
Sample size
Target
245
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6846 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 14511 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294746 0
Government body
Name [1] 294746 0
National Health and Medical Research Council of Australia
Country [1] 294746 0
Australia
Primary sponsor type
Individual
Name
Professor Roslyn Boyd
Address
Queensland Cerebral Palsy Research Centre,
Room 611, Children's Health Research Centre,
62 Graham street,
South Brisbane. 4101. QLD
Country
Australia
Secondary sponsor category [1] 293599 0
University
Name [1] 293599 0
The University of Queensland
Address [1] 293599 0
Centre for Children's Health Research
62 Graham Street,
South Brisbane. 4101. QLD
Country [1] 293599 0
Australia
Other collaborator category [1] 279269 0
Government body
Name [1] 279269 0
Australian E-Health Research Centre, CSIRO
Address [1] 279269 0
The Australian e-Health Research Centre
Health & Biosecurity
Royal Brisbane & Women's Hospital
level 5 UQ Health Science Building 901/16, Royal Brisbane and Women's Hospital, Herston, QLD, 4029
Country [1] 279269 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296164 0
Childrens health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 296164 0
Level 7,
Child Health Research Centre,
62 Graham street.,
South Brisbane.
QLD. 4101.
Ethics committee country [1] 296164 0
Australia
Date submitted for ethics approval [1] 296164 0
18/08/2014
Approval date [1] 296164 0
27/10/2014
Ethics approval number [1] 296164 0
HREC/14/QRCH/329
Ethics committee name [2] 296165 0
The University of Queensland Institutional Human Research Ethics Committee
Ethics committee address [2] 296165 0
The University of Queensland Institutional Human Research Ethics Committee,
UQ Research & Innovation
Cumbrae Stewart Building (72)
The University of Queensland
St Lucia QLD 4072
Ethics committee country [2] 296165 0
Australia
Date submitted for ethics approval [2] 296165 0
28/10/2014
Approval date [2] 296165 0
03/11/2014
Ethics approval number [2] 296165 0
2014001487

Summary
Brief summary
The Predict-CP cohort provides further follow-up at 8-12 years of two overlapping preschool-age cohorts examined from 2-5 years (NHMRC465128 motor and brain development; NHMRC569605 growth, nutrition and physical activity).
This population based cohort study undertakes state-wide surveillance of 245 children with CP born in Queensland (birth years 2006-2009). Children will be classified for Gross Motor Function Classification System (GMFCS); Manual Ability Classification System (MACS), Communication (CSFS) and OPD (EDACS). Outcomes include gross motor function, musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function, communication difficulties, participation, parent and child reported quality of life and medical and allied health resource use. These detailed phenotypical data will be compared to brain macro and micro structure using 3T MRI. Relationships between brain lesion severity and outcomes will be analysed using multilevel mixed-effects models.
Trial website
Trial related presentations / publications
Public notes
The is the further follow-up of a prospective study ACTRN 1261200169820

Contacts
Principal investigator
Name 69822 0
Prof Roslyn N Boyd
Address 69822 0
Room 611,
Queensland Paediatric Rehabilitation Research Centre,
Children's Health Research Centre,
The University of Queensland.
62 Graham street.,
South Brisbane. QLD. 4101
Country 69822 0
Australia
Phone 69822 0
+61 7 3069 7372
Fax 69822 0
+61 7 30697109
Email 69822 0
r.boyd@uq.edu.au
Contact person for public queries
Name 69823 0
Prof Roslyn N Boyd
Address 69823 0
Room 611,
Queensland Paediatric Rehabilitation Research Centre,
Children's Health Research Centre,
The University of Queensland.
62 Graham street.,
South Brisbane. QLD. 4101
Country 69823 0
Australia
Phone 69823 0
+61 7 3069 7372
Fax 69823 0
+61 7 30697109
Email 69823 0
r.boyd@uq.edu.au
Contact person for scientific queries
Name 69824 0
Prof Roslyn N Boyd
Address 69824 0
Room 611,
Queensland Paediatric Rehabilitation Research Centre,
Children's Health Research Centre,
The University of Queensland.
62 Graham street.,
South Brisbane. QLD. 4101
Country 69824 0
Australia
Phone 69824 0
+61 7 3069 7372
Fax 69824 0
+61 7 30697109
Email 69824 0
r.boyd@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5844Informed consent form    371691-(Uploaded-15-11-2019-09-45-12)-Study-related document.pdf
5845Other    Study Flyer 371691-(Uploaded-15-11-2019-09-45-55)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Burgess A, Boyd R, Chatfield MD, et al. Self-care ... [More Details]
Study results articleYes Burgess A, Boyd RN, Chatfield MD, Ziviani J, Wothe... [More Details]
Study results articleYes Burgess A, Boyd RN, Chatfield MD, Ziviani J, Sakze... [More Details]

Documents added automatically
No additional documents have been identified.