Assessment of a Feeding Difficulties Diagnostic Tool Questionnaire For Children With Oral Feeding Resistance (FDDT)
|ClinicalTrials.gov Identifier: NCT02377596|
Recruitment Status : Withdrawn (Not enough participants)
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
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.
|Condition or disease|
|Feeding Difficulties Feeding and Eating Disorders of Childhood|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Assessment of a Feeding Difficulties Diagnostic Tool Questionnaire For Children With Oral Feeding Resistance|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Perceived Feeding Difficulties
To complete the study we will recruit at least 40 of the children perceived by their parents or guardian to have feeding difficulties.
- To determine the degree of concordance between diagnoses arrived at by pediatricians using the FDDT questionnaire with those reached by trained experts in pediatric feeding difficulties using their standard assessment. [ Time Frame: during wellness visit (1x) at enrollment ]To determine the degree of concordance between diagnoses arrived at by pediatricians using the FDDT questionnaire (completed in the pediatric office visit) with those reached by trained experts in pediatric feeding difficulties using their standard assessment (completed over the telephone and recorded).
- The acceptance and practicality of use of the FDDT by office staff, pediatricians, and patients. (brief questionnaire assessing the practicality of the FDDT measure and the overall acceptance of the measure.) [ Time Frame: during wellness visit (1x) at enrollment ]The acceptance and practicality of use of the FDDT by office staff, pediatricians, and patients. The office staff, the pediatricians, and the patients will each fill out a brief questionnaire assessing the practicality of the FDDT measure and the overall acceptance of the measure.
- Weight [ Time Frame: during wellness visit (1x) at enrollment ]We will collect data on the patient's body weight.
- Height [ Time Frame: during wellness visit (1x) at enrollment ]We will collect data on the patient's height.
- Growth Index [ Time Frame: during wellness visit (1x) at enrollment ]We will collect data on the patient's percent of ideal body weight based on weight for height in children less than 2 years of age and body mass index (BMI) in the older child for each of the diagnostic groups
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377596
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Benny Kerzner, MD||Children's National Research Institute|