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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

Brief Summary:

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

    Detailed Summary:

    Background:

    Surveys conducted throughout the world repeatedly demonstrate that approximately 50% of mothers consider at least one of their children to have a feeding difficulty, meaning that they resist taking an appropriate amount of food. This implicates between 20% and 30% of all children. The milder cases are frequently considered "picky eaters" and although well nourished they are at significant risk for coercive feeding. This in turn has been associated with cognitive limitations and behavioral problems. Sub-groups do exhibit poor growth, and some have sub-optimal nutrient consumption relative to body size,while others have underlying or co-morbid organic disease. To help identify the relevant intervention for these children, whether it is reassurance for the parents, counseling to resolve behavioral problems (of both the child and the feeder), nutritional intervention and/or medical treatment, it is necessary to identify the separate conditions that contribute to the feeding difficulty and its complications so that appropriate treatment can then be tailored to the cause.

    The task of categorizing children with feeding problems is frequently daunting for the pediatrician due to time constraints and lack of training in this field. In developed countries, physicians may refer a child with severe feeding difficulties to a specialist; however, in many parts of the world, these resources are limited or absent. Additionally, health care professionals have a narrow perspective based on their specialized training, whether that is general medical care, specialized care, nutrition, or oral motor therapy.

    To overcome the limitations detailed above, a questionnaire was developed based on the work of the principal investigator, Dr. Kerzner and the co-investigator, Dr. Cha
    Sponsor: Benny Kerzner, MD

    Current Primary Outcome:

    • 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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


    Original Secondary Outcome: Same as current

    Information By: Children's Research Institute

    Dates:
    Date Received: May 14, 2012
    Date Started: December 2011
    Date Completion:
    Last Updated: February 25, 2015
    Last Verified: February 2015