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

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ClinicalTrials.gov Identifier: NCT02377596
Recruitment Status : Withdrawn (Not enough participants)
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
Benny Kerzner, MD, Children's National Research Institute

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 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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
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.



Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Weight [ Time Frame: during wellness visit (1x) at enrollment ]
    We will collect data on the patient's body weight.

  2. Height [ Time Frame: during wellness visit (1x) at enrollment ]
    We will collect data on the patient's height.

  3. 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



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Ages Eligible for Study:   12 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective, observational pilot study will be conducted in a single private pediatric office. The pediatricians have incorporated the FDDT questionnaire as a part of the routine evaluation of children coming for "well baby visits". To complete the study we will recruit at least 40 of the children perceived by their parents or guardian to have feeding difficulties. To be sure this number is obtained we will aim to recruit 50 subjects.
Criteria

Inclusion Criteria:

  1. Patient is between 12 and 60 months of age
  2. Parent or legal guardian is concerned that the patient's feeding behavior is aberrant
  3. 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
  4. Parent or legal guardian states their willingness to complete any forms and participate in the telephone interviews needed throughout the study

Exclusion Criteria:

  1. 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)
  2. Patients currently receiving parenteral or supplemental therapeutic enteral nutrition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377596


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Benny Kerzner, MD
Abbott Nutrition
Investigators
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Principal Investigator: Benny Kerzner, MD Children's National Research Institute
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Responsible Party: Benny Kerzner, MD, MD, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02377596    
Other Study ID Numbers: ANUS1108
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Keywords provided by Benny Kerzner, MD, Children's National Research Institute:
Feeding
difficulties
disorders
childhood
eating
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Feeding and Eating Disorders of Childhood
Mental Disorders