The Pediatric Eating Assessment Tool

Cerebral Palsy Clinical Trial

Official title:

The Development of the Pediatric Eating Assessment Tool (PEDI-EAT-10)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909127
• Other study ID #: PEDI-EAT-10
• Status: Completed
• Start date: September 21, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The evaluation of pediatric swallowing disorders includes clinical and instrumental techniques. The clinical evaluation is important for clinical decision-making and to assess the need for an instrumental evaluation of swallowing. A recent systematic review suggested that the currently available non-instrumental assessments for clinicians to evaluate swallowing and feeding function in the pediatric population have wide variations in design, assessment domains, and target groups. It was concluded that there is a significant need for standardized assessment tools with good psychometric properties in the pediatric population. The existing instruments measure the presence or absence and frequency of challenges related to eating/feeding problems in pediatrics, they do not comprehensively measure oropharyngeal phase swallowing problems or do not reflect the severity of oropharyngeal dysphagia symptoms. The 10-item Eating Assessment Tool (EAT-10), which was designed for adult patients, is a good model for this current research. It has proven highly successful in quantifying initial dysphagia symptom severity and in monitoring treatment efficacy in a vast array of dysphagia etiologies. Although the EAT-10 is a symptom survey, it has been able to predict objective evidence of swallowing dysfunction. There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population such as the EAT-10. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months and older

Eligibility

The inclusion criteria are:

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

The exclusion criteria are:

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• SWALLOWING EVALUATION
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.
• The Functional Independence Measure
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.
• The PEDI-EAT-10
The PEDI-EAT-10 will also be administered.

Locations

Country	Name	City	State
Turkey	Hacetttepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigation of the psychometric properties of the scale	The PEDI-EAT-10 will be administered to the primary feeders of the CP children on two separate occasions separated by at least 48 hours to evaluate test-retest reliability. The criterion-related validity of the PEDI-EAT-10 will be assessed by the correlation between the PEDI-EAT-10 and swallowing evaluation results.	6 MONTHS