Assessment of a Feeding Difficulties Diagnostic Tool Questionnaire For Children With Oral Feeding Resistance

Withdrawn before enrolling

Conditions studied: Feeding Difficulties, Feeding and Eating Disorders of Childhood

In brief

Our long term objective is to enhance the pediatrician's management of children with feeding difficulties in a primary care office-based pediatric practice setting. A prerequisite is to rapidly reach an accurate diagnosis so that appropriate therapy can be applied. To improve the efficiency and accuracy of the diagnostic interview the investigators have designed a Feeding Difficulty Diagnostic Tool (FDDT) consisting of a set of questions that fit beneath a 'diagnostic cover' and prompts for basic information. Depending on the answers rendered on the questionnaire particular diagnoses noted on the cover are flagged for consideration. In this study our specific objectives are 1) to assess the feasibility and acceptability of using the FDDT in the pediatrician's office and 2) to obtain preliminary data on the reliability of using the instrument in the diagnosis and management of children with feeding difficulties. * Feasibility and acceptability are often interrelated and will be assessed in a broad sense by questionnaires that ascertain, for example, the amount of time needed by parents and staff to fill in and use the FDDT questionnaire, the ease and difficulties encountered in filling out the FDDT questionnaire and the understanding of the questionnaire by the parents. * Reliability relates to the usefulness of the FDDT questionnaire for the pediatrician in obtaining and organizing the information obtained from the history and physical including anthropometric data to reach a correct diagnosis, the latter being judged in this study against the diagnosis reached independently by trained experts in pediatric feeding difficulties using a modification of their standard diagnostic interview. The frequency of presentation of the various diagnostic sub-categories and the extent of the discrepancy between the conclusions suggested by the FDDT, the pediatrician, and the feeding disorder experts is unknown. Therefore' this pilot study is needed to help determine the sample size necessary to power a more definitive study of the diagnostic tool's accuracy, if necessary. The investigators anticipate that at least three of the categories (children with excessive selectivity, children with demonstrably poor appetite who are vigorous and free of organic disease, and those misperceived to have feeding limitations) will be well represented in this preliminary study.

Key facts

Study ID: NCT02377596
Run by: Benny Kerzner, MD
People needed: 0
Starts: 2011-12-01
Expected to finish: 2014-08-01
Last updated by the study team: 2015-03-03

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is between 12 and 60 months of age
Parent or legal guardian is concerned that the patient's feeding behavior is aberrant
Parent or legal guardian voluntarily signs and dates an informed consent to participate in the study and provides authorization to use and/or disclose personal health data
Parent or legal guardian states their willingness to complete any forms and participate in the telephone interviews needed throughout the study

You may not qualify if…

Patients with overt, serious organic disease, including:
Aspiration with swallowing
Developmental delay
Cardiorespiratory difficulty interfering with eating
Intestinal obstruction
Disorders restricting dietary intake, such as diabetes, celiac disease and food allergy f. Known genetic disorders ( e.g., chromosomal trisomies)
Patients currently receiving parenteral or supplemental therapeutic enteral nutrition

Where it is running

Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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