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Completed

NCT Number: NCT03026491

Chewing 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.

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Key information

Conditions

Chewing Problem

Age range

24 month–192 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 10 minutes

    Chewing function will be evaluated

Secondary outcomes

  1. Observational oral motor assessment will be performed

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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