The Pediatric Eating Assessment Tool

NCT02909127 | Completed DMC

• 1 other identifier: PEDI-EAT-10
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.

Conditions

Cerebral Palsy

Keywords

deglutition; deglutition disorders; pediatric dysphagia; swallowing

Outcome Measures

Primary Outcomes (1)

• Development of the scale steps

  A comprehensive pediatric dysphagia literature review and the validated items from the other scales will be used to create the items of the PEDI-EAT-10. The PEDI-EAT-10 was designed as a parent-report measure of dysphagia symptom severity. Content validity will also be investigated because it is the first stage of instrument development. An expert panel with Delphi rounds will be convened to determine the initial content validity. The experts will be scored each item of the scale as ''necessary'', ''insufficent'' or ''unnecessary'' and the content validity index (CVI) will be calculated.

  10 days

Secondary Outcomes (1)

• Investigation of the psychometric properties of the scale

  6 MONTHS

Study Arms (2)

Cerebral palsied children

The inclusion criteria are age above 18 months, fed orally, referred due to parent complaints about their child's swallowing function and not admitted a swallowing center before. Swallowing evaluation will be performed. The Functional Independence Measure and PEDI-EAT-10 will be filled.

Other: SWALLOWING EVALUATION; Other: The Functional Independence Measure; Other: The PEDI-EAT-10

Healthy children

Healthy children above the age of 18 months with no medical history of voice, swallowing, reflux, airway, neurologic, rheumatologic, or neoplastic disorders will be included for normative data generation. The PEDI-EAT-10 will be filled.

Other: The PEDI-EAT-10

Interventions

SWALLOWING EVALUATION OTHER

Swallowing function of the CP patients will be imaged and recorded with Videofluoroscopic Swallowing Study (VFSS). The oral cavity, pharynx, larynx and just below the upper esophageal sphincter are visible. 3 trials of 3 ml of liquids will be used and the worst score will be considered for calculation. The Penetration-Aspiration Scale (PAS) will be used to assess dysphagia severity. The PAS is an ordinal scale consisting of eight scores. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.

Cerebral palsied children

The Functional Independence Measure OTHER

The Functional Independence Measure for Children (Wee-FIM) will be used to assess the functional independence level of the CP children. The Wee-FIM is developed to emphasize habilitative and developmental aspects of children with special health care needs, genetic disorders, developmental disabilities, and acquired disabilities.

Cerebral palsied children

The PEDI-EAT-10 OTHER

The PEDI-EAT-10 will also be administered.

Cerebral palsied children; Healthy children

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children with spastic cerebral palsy (CP) will be included to test internal consisteny, test-retest reliability and criterion validity.

You may qualify if:

• Age above 18 months,
• Fed orally,
• Referred due to parent complaints about their child's swallowing function,
• Not admitted a swallowing center before.

You may not qualify if:

• Age below 18 months,
• Fed nonorally,
• No parent complaints about their child's swallowing function,
• Admitted a swallowing center before.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• Lefton-Greif MA. Pediatric dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):837-51, ix. doi: 10.1016/j.pmr.2008.05.007.

  PMID: 18940644 BACKGROUND

• Arvedson JC. Assessment of pediatric dysphagia and feeding disorders: clinical and instrumental approaches. Dev Disabil Res Rev. 2008;14(2):118-27. doi: 10.1002/ddrr.17.

  PMID: 18646015 RESULT

• Serel Arslan S, Kilinc HE, Yasaroglu OF, Demir N, Karaduman AA. The pediatric version of the eating assessment tool-10 has discriminant ability to detect aspiration in children with neurological impairments. Neurogastroenterol Motil. 2018 Nov;30(11):e13432. doi: 10.1111/nmo.13432. Epub 2018 Aug 13.

  PMID: 30101572 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Deglutition Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

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: PT, PhD

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 21, 2016
• Study Start: September 21, 2016
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

TU (1)