Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Chewing Problem Clinical Trial

Official title:

Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026491
• Other study ID #: EA-TEF
• 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
• 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

Related Conditions & MeSH terms

• Chewing Problem
• Esophageal Atresia
• Fistula
• Tracheoesophageal Fistula

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