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Completed

NCT Number: NCT02909127

The Pediatric Eating Assessment Tool

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.

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

The PEDI-EAT-10

Other

The PEDI-EAT-10 will also be administered.

Primary outcomes

  1. Development of the scale steps

    Time frame: 10 days

    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.

Secondary outcomes

  1. Investigation of the psychometric properties of the scale

    Time frame: 6 MONTHS

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2016
Registry last updated
Jan 5, 2024

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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