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

NCT02377596 | Withdrawn

• 1 other identifier: ANUS1108
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Difficulties; Feeding and Eating Disorders of Childhood

Keywords

Feeding; difficulties; disorders; childhood; eating

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  during wellness visit (1x) at enrollment

• 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.)

  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.

  during wellness visit (1x) at enrollment

Secondary Outcomes (3)

• Weight

  during wellness visit (1x) at enrollment

• Height

  during wellness visit (1x) at enrollment

• Growth Index

  during wellness visit (1x) at enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

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

Sponsors & Collaborators

• Benny Kerzner, MD: lead
• Abbott Nutrition: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood; Disease

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benny Kerzner, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: March 3, 2015
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

US (1)