Chewing ProblemNCT03026491
Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
An observational study of Chewing Problem, run by Hacettepe University.
Trial summary
The investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Read more about this study
- Who is it for?
- Ages 24 to 192 monthsHealthy volunteers can take part
- Conditions the study is for
- Chewing Problem
- What is being tested?
- Chewing evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Apr 2017
- 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 192 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with repaired esophageal atresia-tracheoesophageal fistula
Who may be able to join
- Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure
Who cannot join
- Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure
About this study
Official title: Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
The investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
Read the detailed description
The diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. It is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
- Conditions
- Chewing Problem
- Being tested
- Chewing evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing evaluationOther
Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).
| Study group | Role | What they receive |
|---|---|---|
| Children with chewing dysfunction | Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children. Receives: Other: Chewing evaluation | |
| Children without chewing dysfunction | Descriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children. Receives: Other: Chewing evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)
Chewing function will be evaluated
Measured: 10 minutes
Secondary outcomes (1)
Observational oral motor assessment will be performed
The presence of open mouth posture, open bite, tongue thrust, high palate will be noted as ''absent'' or ''present''. The body position, hyper/hyposensitivity, jaw, lips/cheeks and tongue movements of the children will be assessed .
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Mar 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chewing ProblemStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 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
- NCT03026491
- Sponsor's protocol ID
- EA-TEF
- Status last verified
- Aug 2017
- First submitted
- 15 Jan 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
- ClinicalTrials.gov ID
- NCT03026491
- Acronym / sponsor ID
- EA-TEF
- Conditions
- Chewing Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 20 Jan 2017 (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 investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
Detailed description
The diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. It is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with chewing dysfunction | – | Other: Chewing evaluationDescriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children. |
| Children without chewing dysfunction | – | Other: Chewing evaluationDescriptive characteristics including age, height, weight, transition time to additional food, meal time, number of meals, initial teething time, and number of teeth, were noted. The presence of open mouth, open bite, high palate, gag reflex, and oral hygiene were scored as absent or present as an observational oral motor assessment. Chewing evaluation was performed and scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) was used to determine the tolerated food texture of children. |
Who may qualify
- Ages
- 24 to 192 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with repaired esophageal atresia-tracheoesophageal fistula
Key inclusion criteria (1 listed)
- Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure
Key exclusion criteria (1 listed)
- Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure
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 |
|---|---|---|
| Chewing evaluationEach child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS). | Other | Children with chewing dysfunction, Children without chewing dysfunction |
Primary outcome
Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)
Time frame: 10 minutes
Chewing function will be evaluated
1 secondary outcome
Observational oral motor assessment will be performed
Time frame: 15 minutes
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 9 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Chewing Problem
Active, not recruiting
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study
Chewing Problem, Cognitive Decline
Not yet recruitingObservational study
Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Mastication Disorder, Fatigue
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
Questions about this trial
What is this clinical trial studying?
An observational study of Chewing Problem, run by Hacettepe University.
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 1 inclusion and 1 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS) (time frame: 10 minutes). 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 9 Aug 2017.