- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777645
Growth, Dietary Intakes and Feeding Behaviors of Children With Cerebral Palsy Who Have Chewing Disorders
May 18, 2016 updated by: SELEN SEREL ARSLAN, Hacettepe University
The nutritional status of CP children may be decreased when children have chewing disorders too due to insufficient solid food intake.
The objective of this study was to investigate growth, dietary intakes and feeding behaviours of children with CP who have chewing disorders, and to compare them with their healthy peers.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Chewing function is defined as a rhythmic oral motor activity to comminute and soften solid food.
Children with CP often have difficulty in transitioning to solid food.
The main food of 45% of them was liquids and semisolids.
It was reported that food/fluid textures were modified for 39% of children in which with poorer gross motor function tended to receive a greater proportion of energy from fluids in their diets and fewer chewable foods.
Lopes et al. investigated dietary patterns of 90 children with CP aged 2-13 years by using the 24-hour recall method and found that 26% and 9% of children had difficulty in chewing and swallowing of solid foods, respectively.
However, the diet of children with normal feeding skills includes liquid, semisolid and/or solid foods together so unable to take any solid food may affect sufficient food intake and nutritional status of children with CP who have chewing disorders.
The significance of this situation is that nutritional status has effects on general health and quality of life of children and their families.
Therefore, it is important to show the nutritional status of CP children with chewing disorders to increase the awareness of both parents and healthcare providers on solid food intake and solve the problem early.
The objective of this study was to investigate growth, dietary intakes and feeding behaviours of children with CP who have chewing disorders, and to compare them with their healthy peers.
Study Type
Observational
Enrollment (Actual)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Hacetttepe University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Group I (study group) (n=50) included CP children with chewing disorders and group II (control group) (n=35) included healthy children without chewing disorders
Description
Inclusion Criteria:
Study group
- Children with cerebral palsy
- Having complaints about chewing function
- Do not manage solid food intake
- Above the age of 18 months Control group
- Healthy children
- No complaints about chewing function
- Can manage solid food intake
- Above the age of 18 months
Exclusion Criteria:
- Under the age of 18 months
- Requiring tube feeding or taking any oral nutritional supplements
- Using any medicine and/or oral appliances that could affect the chewing performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Study group(n=50) included CP children with chewing disorder.
Growth, feeding evaluation will be done.
|
Z-scores of the nutritional indicators were calculated.
The dietary assessment was performed by using the 24-hour recall method.
The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions
|
|
Control group
Control group(n=35)= healthy children without chewing disorder Growth, feeding evaluation will be done.
|
Z-scores of the nutritional indicators were calculated.
The dietary assessment was performed by using the 24-hour recall method.
The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth of children with cerebral palsy (CP) who have chewing disorders (Z-scores)
Time Frame: 3 months
|
Z-scores of the nutritional indicators were calculated.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intakes of children with cerebral palsy (CP) who have chewing disorders (dietary assessment)
Time Frame: 3 months
|
The dietary assessment was performed by using the 24-hour recall method.
|
3 months
|
|
Feeding behaviours of children with cerebral palsy (CP) who have chewing disorders (BPFAS)
Time Frame: 3 months
|
The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
May 13, 2016
First Submitted That Met QC Criteria
May 18, 2016
First Posted (ESTIMATE)
May 19, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
May 19, 2016
Last Update Submitted That Met QC Criteria
May 18, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ArslanSerel1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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