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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03026491
Other study ID # EA-TEF
Secondary ID
Status Completed
Phase N/A
First received January 15, 2017
Last updated August 8, 2017
Start date January 1, 2017
Est. completion date April 1, 2017

Study information

Verified date August 2017
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date April 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Months to 192 Months
Eligibility Inclusion Criteria:

- Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure

Exclusion Criteria:

- Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure

Study Design


Intervention

Other:
Chewing evaluation
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Outcome

Type Measure Description Time frame Safety issue
Primary Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS) Chewing function will be evaluated 10 minutes
Secondary 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 . 15 minutes
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