Cerebral PalsyNCT02777645
Growth, Dietary Intakes and Feeding Behaviors of Children With Cerebral Palsy Who Have Chewing Disorders
An observational study of Cerebral Palsy and Mastication Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 24 to 61 months
- Conditions the study is for
- Cerebral Palsy, Mastication Disorder, Malnutrition
- What is being tested?
- Growth, feeding evaluation
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 61 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Show all 9Show fewer
- No complaints about chewing function
- Can manage solid food intake
- Above the age of 18 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Mastication Disorder, Malnutrition, Growth Delay
- Being tested
- Growth, feeding evaluation
- Medical subject headings
- Cerebral Palsy, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth, feeding evaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Study group(n=50) included CP children with chewing disorder. Growth, feeding evaluation will be done. Receives: Other: Growth, feeding evaluation | |
| Control group | Control group(n=35)= healthy children without chewing disorder Growth, feeding evaluation will be done. Receives: Other: Growth, feeding evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of children with cerebral palsy (CP) who have chewing disorders (Z-scores)
Z-scores of the nutritional indicators were calculated.
Measured: 3 months
Secondary outcomes (2)
Dietary intakes of children with cerebral palsy (CP) who have chewing disorders (dietary assessment)
The dietary assessment was performed by using the 24-hour recall method.
Measured: 3 months
Feeding behaviours of children with cerebral palsy (CP) who have chewing disorders (BPFAS)
The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- Selen SEREL ARSLAN, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777645
- Sponsor's protocol ID
- ArslanSerel1
- Status last verified
- May 2016
- First submitted
- 13 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Dietary Intakes and Feeding Behaviors of Children With Cerebral Palsy Who Have Chewing Disorders
- ClinicalTrials.gov ID
- NCT02777645
- Acronym / sponsor ID
- ArslanSerel1
- Conditions
- Cerebral Palsy, Mastication Disorder, Malnutrition, Growth Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Growth, feeding evaluationStudy group(n=50) included CP children with chewing disorder. Growth, feeding evaluation will be done. |
| Control group | – | Other: Growth, feeding evaluationControl group(n=35)= healthy children without chewing disorder Growth, feeding evaluation will be done. |
Who may qualify
- Ages
- 24 to 61 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth, feeding evaluationZ-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 | Other | Control group, Study group |
Primary outcome
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.
2 secondary outcomes
Dietary intakes of children with cerebral palsy (CP) who have chewing disorders (dietary assessment)
Time frame: 3 months
Feeding behaviours of children with cerebral palsy (CP) who have chewing disorders (BPFAS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selen SEREL ARSLAN, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Mastication Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of children with cerebral palsy (CP) who have chewing disorders (Z-scores) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.