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Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

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ClinicalTrials.gov Identifier: NCT03026491
Recruitment Status : Completed
First Posted : January 20, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
SELEN SEREL ARSLAN, 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.

Condition or disease Intervention/treatment
Chewing Problem Other: Chewing evaluation

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 Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : April 1, 2017


Group/Cohort Intervention/treatment
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
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 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
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 Outcome Measures :
  1. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS) [ Time Frame: 10 minutes ]
    Chewing function will be evaluated


Secondary Outcome Measures :
  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 .



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Ages Eligible for Study:   24 Months to 192 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with repaired esophageal atresia-tracheoesophageal fistula
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026491


Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: SELEN SEREL ARSLAN, PhD Hacettepe University

Responsible Party: SELEN SEREL ARSLAN, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03026491     History of Changes
Other Study ID Numbers: EA-TEF
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fistula
Esophageal Atresia
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Esophageal Fistula
Digestive System Fistula
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases