Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Completed

• Conditions: Chewing Problem
• Interventions: Other: Chewing evaluation

• Registration Number: NCT03026491
• Lead Sponsor: Hacettepe University

Brief 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.

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Primary Completion: 2017-03-01
• Study Completion: 2017-04-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children without chewing dysfunction	Chewing evaluation	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.
Children with chewing dysfunction	Chewing evaluation	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.

Primary Outcome Measures

Name	Time	Method
Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)	10 minutes	Chewing function will be evaluated

Secondary Outcome Measures

Name	Time	Method
Observational oral motor assessment will be performed	15 minutes	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 .