Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

NCT03026491 | Completed DMC

• 1 other identifier: EA-TEF
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chewing Problem

Outcome Measures

Primary Outcomes (1)

• Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)

  Chewing function will be evaluated

  10 minutes

Secondary Outcomes (1)

• Observational oral motor assessment will be performed

  15 minutes

Study Arms (2)

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.

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.

Other: Chewing evaluation

Interventions

Chewing evaluation OTHER

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).

Children with chewing dysfunction; Children without chewing dysfunction

Eligibility Criteria

• Age: 24 Months - 192 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with repaired esophageal atresia-tracheoesophageal fistula

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Officials

• SELEN SEREL ARSLAN, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share