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Trial registered on ANZCTR


Registration number
ACTRN12616001419459
Ethics application status
Approved
Date submitted
26/09/2016
Date registered
12/10/2016
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Red Flags for Feeding and Nutrition for Children with Cerebral Palsy
Scientific title
Red Flags for the Identification of Feeding Difficulties and Undernutrition in Children and Adolescents with Cerebral Palsy
Secondary ID [1] 290217 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 300395 0
Condition category
Condition code
Diet and Nutrition 300257 300257 0 0
Other diet and nutrition disorders
Neurological 300258 300258 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to develop and validate brief questionnaire (up to 5 questions) to identify those children and adolescents with cerebral palsy who may have feeding difficulties are be undernourished. This would allow children to be referred for full assessment by the relevant health care professional/s to determine the presence and severity of feeding and swallowing difficulties and/or undernutrition and lead to the provision of appropriate clinical care.

A total of 100 children between the ages of 2.00 and 17.99 years will be recruited for the study. To be enrolled, children must have a confirmed diagnosis of cerebral palsy and not rely on a feeding tube for enteral nutrition. We will aim to recruit an even distribution across gross motor functional severity.

Parents will be asked to answer a series of simple questions regarding their child's feeding and nutritional status. Full feeding assessment and nutrition assessment will then be conducted to determine the presence and severity or absence of feeding difficulties and undernutrition. These will all be conducted on the same day.

The nutritional assessment will consist of measures of weight and height (or length or knee height) and triceps and subscapular skinfold thicknesses. A Subjective Global Nutrition Assessment will be performed which involves an interview with the child's primary care giver and the collection of a nutrition related medical history including historical weight and height measurements (if known), full dietary history, presence and severity of gastrointestinal symptoms, and other related medical information. A physical examination of key physical signs associated with undernutrition including subcutaneous fat stores and muscle stores will be conducted.

The feeding evaluation will involve the child positioned in their typical mealtime seating, children will be encouraged to consume food and fluids of different textures.

When required children will be referred for a more detailed feeding evaluation using an x-ray procedure. This may be conducted on a separate day to the other components.
Intervention code [1] 295986 0
Diagnosis / Prognosis
Comparator / control treatment
Full feeding and swallowing assessment and full nutritional assessment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299731 0
Presence and severity of feeding and swallowing difficulties determined via a clinical feeding evaluation completed by a speech pathologist. This is a composite outcome.
Timepoint [1] 299731 0
Once only assessment during typical mealtime
Primary outcome [2] 299843 0
Nutrition Assessment: Well-nourished, moderately malnourished, severely malnourished as determined by full nutrition assessment
Timepoint [2] 299843 0
Once only assessment
Secondary outcome [1] 328292 0
Validity of the questionnaire for identifying children with feeding and swallowing difficulties. We will use McNemar’s Test to investigate the percentage of children defined as having feeding difficulties by the screening questionnaire and by the feeding and swallowing assessment.
Timepoint [1] 328292 0
Once only assessment
Secondary outcome [2] 328293 0
Validity of the questionnaire for determining nutritional status. We will use McNemar’s Test to investigate the percentage of children defined as being undernourished by the screening questionnaire and by the subjective global nutrition assessment.
Timepoint [2] 328293 0
once only assessment

Eligibility
Key inclusion criteria
Children with a confirmed diagnosis of cerebral palsy
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Enteral nutrition via a feeding tube

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
A total of 100 children, 20 from each of the five GMFCS stratum will be required for this study. Although formal sample size calculations for studies concerning the measurement properties of tools rely on too many assumptions to be of much use practically, a sample size of 100 is considered to be “excellent” by the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) group. This sample size is comparable to those utilised by previous studies where nutritional screening tools have been developed.

To develop the screening tool we will first determine the individual contribution each screening questions makes towards identifying children with feeding difficulties and undernutrition (as defined above) by undertaking a principal components factor analysis.

To validate the screening tool we will use the identified cutoff scores for feeding and swallowing difficulties and undernutrition, and the DDS and videofluoroscopy and subjective global nutrition assessment to calculate the sensitivity, specificity, predictive values and likelihood ratios for the screening tool. We will use McNemar’s Test to investigate the percentage of children defined as having feeding difficulties and undernutrition by the screening tool and by the subjective global nutrition assessment.
The model will be validated using ten-fold-cross-validation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2016
Actual
1/02/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
13/03/2018
Date of last data collection
Anticipated
29/12/2017
Actual
13/03/2018
Sample size
Target
100
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6716 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 14362 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294579 0
Commercial sector/Industry
Name [1] 294579 0
Danone, Nutricia
Country [1] 294579 0
Netherlands
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Child Health Research
Graham Street
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 293448 0
None
Name [1] 293448 0
Address [1] 293448 0
Country [1] 293448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296015 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 296015 0
Ethics committee country [1] 296015 0
Australia
Date submitted for ethics approval [1] 296015 0
10/10/2016
Approval date [1] 296015 0
07/11/2016
Ethics approval number [1] 296015 0
HREC/16/QRCH/339
Ethics committee name [2] 296016 0
The University of Queensland Medical Research Ethics Committee (EC00179)
Ethics committee address [2] 296016 0
Ethics committee country [2] 296016 0
Australia
Date submitted for ethics approval [2] 296016 0
01/11/2016
Approval date [2] 296016 0
25/01/2017
Ethics approval number [2] 296016 0
2016001695/HREC/16/QRCH/339
Ethics committee name [3] 296017 0
Griffith University Human Research Ethics Committee (EC00162)
Ethics committee address [3] 296017 0
Ethics committee country [3] 296017 0
Australia
Date submitted for ethics approval [3] 296017 0
01/11/2016
Approval date [3] 296017 0
Ethics approval number [3] 296017 0
Ethics committee name [4] 302639 0
CPL Human Research Ethics Committee
Ethics committee address [4] 302639 0
Ethics committee country [4] 302639 0
Australia
Date submitted for ethics approval [4] 302639 0
11/08/2017
Approval date [4] 302639 0
25/09/2017
Ethics approval number [4] 302639 0
CPL-2017-003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69270 0
Dr Kristie Bell
Address 69270 0
Children's Nutrition Research Centre,
Child Health Research Centre,
Level 6 Centre for Child Health Research,
University of Queensland,
62 Graham Street
South Brisbane QLD 4101
Country 69270 0
Australia
Phone 69270 0
+61 7 3069 7451
Fax 69270 0
Email 69270 0
[email protected]
Contact person for public queries
Name 69271 0
Kristie Bell
Address 69271 0
Children's Nutrition Research Centre,
Child Health Research Centre,
Level 6 Centre for Child Health Research,
University of Queensland,
62 Graham Street
South Brisbane QLD 4101
Country 69271 0
Australia
Phone 69271 0
+61 7 3069 7451
Fax 69271 0
Email 69271 0
[email protected]
Contact person for scientific queries
Name 69272 0
Kristie Bell
Address 69272 0
Children's Nutrition Research Centre,
Child Health Research Centre,
Level 6 Centre for Child Health Research,
University of Queensland,
62 Graham Street
South Brisbane QLD 4101
Country 69272 0
Australia
Phone 69272 0
+61 7 3069 7451
Fax 69272 0
Email 69272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
individual data will not be available. All publicly available data will be reported for the group, not for individuals, as per our ethical approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.