Feeding DifficultiesFDDTNCT02377596
Assessment of a Feeding Difficulties Diagnostic Tool Questionnaire For Children With Oral Feeding Resistance
An observational study of Feeding Difficulties and Feeding and Eating Disorders of Childhood, run by Benny Kerzner, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Feeding Difficulties, Feeding and Eating Disorders of Childhood
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the detailed description
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. Chatoor. This questionnaire is filled out by the parents and their responses prompt the physician to consider relevant diagnostic possibilities for the particular child's feeding difficulty. Once a diagnosis or set of diagnoses is established by utilization of the questionnaire, specific and appropriate therapy can then be provided.
The diagnostic categories that are captured by this tool are based on typical symptoms demonstrated by children with feeding difficulties and their basis has been published by the principal investigator (copy attached).1 Children over one year of age are divided into three groups based on their dominant symptoms: those with poor appetite; those with excessive selectivity; and those with fear of feeding. Children with a poor appetite are further categorized into four sub groups: those who have underlying organic or medical problems; those who are very active and playful but whose poor feeding leads to conflict with the mother; those who fail to-thrive based on poor economic circumstances or neglect; and, finally, those who are eating appropriate amounts of food but are misperceived by their caregivers to have a poor appetite. Each feeding difficulty category has different and unique approaches necessary for its resolution and it is possible for a child to fit into more than one diagnostic category
As the diagnostic nomenclature in the literature has been confusing and in a state of flux there are no data on the relative prevalence of various diagnoses, much less on the diagnostic categories used in the current classification. Consequently, we have minimal guidance for decisions relating to sample size; thus, the need for a pilot study. We believe that this study will allow us an insight into the frequency and variance in diagnosis of at least three of the major categories: children who are vigorous but with poor appetite, those who are highly selective, and those who are in fact misperceived to have a feeding problem. We also have no information on the feasibility and acceptance of the FDDT questionnaire and we believe the pilot study will facilitate our gaining the pediatrician's and office staff's perspective so that in future designs of the instrument we can overcome any practical limitations that become evident.
Design:
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. This study will be approximately one year in duration.
Data Collection:
The following data will be collected on study subjects as illustrated in the flow sheet on page 6 of this research protocol cover sheet.
- Historical data reported by the parent or guardian on the FDDT questionnaire
- The diagnosis suggested on the Cover sheet of the FDDT
- The pediatrician's details of the patient's physical examination, anthropometrics and calculations (weight and length or height percentiles and mid parental height). A prompt for these data is available in the FDDT. The patient's name will blacked out and a study subject number will be inserted.
- Data on the acceptance of the FDDT will be obtained from the office staff, the pediatricians, and the patients' parents.
- The diagnosis reached by the first feeding specialist (CPNP)
- The diagnosis reached by the second feeding specialist (Psychiatrist)
- Keywords
- Feeding, difficulties, disorders, childhood, eating
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: during wellness visit (1x) at enrollment
Secondary outcomes (3)
Weight
We will collect data on the patient's body weight.
Measured: during wellness visit (1x) at enrollment
Height
We will collect data on the patient's height.
Measured: during wellness visit (1x) at enrollment
Growth Index
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
Measured: during wellness visit (1x) at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DifficultiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benny Kerzner, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Sponsor-investigator, Benny Kerzner, MD, Children's National Research Institute
- Investigators
- Benny Kerzner, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377596
- Sponsor's protocol ID
- ANUS1108
- Acronym
- FDDT
- Status last verified
- Feb 2015
- First submitted
- 14 May 2012
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Feeding Difficulties Diagnostic Tool Questionnaire For Children With Oral Feeding Resistance
- ClinicalTrials.gov ID
- NCT02377596
- Acronym / sponsor ID
- FDDT / ANUS1108
- Keywords
- Feeding, difficulties, disorders, childhood, eating
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not enough participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Benny Kerzner, MDUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Chatoor. This questionnaire is filled out by the parents and their responses prompt the physician to consider relevant diagnostic possibilities for the particular child's feeding difficulty. Once a diagnosis or set of diagnoses is established by utilization of the questionnaire, specific and appropriate therapy can then be provided.
The diagnostic categories that are captured by this tool are based on typical symptoms demonstrated by children with feeding difficulties and their basis has been published by the principal investigator (copy attached).1 Children over one year of age are divided into three groups based on their dominant symptoms: those with poor appetite; those with excessive selectivity; and those with fear of feeding. Children with a poor appetite are further categorized into four sub groups: those who have underlying organic or medical problems; those who are very active and playful but whose poor feeding leads to conflict with the mother; those who fail to-thrive based on poor economic circumstances or neglect; and, finally, those who are eating appropriate amounts of food but are misperceived by their caregivers to have a poor appetite. Each feeding difficulty category has different and unique approaches necessary for its resolution and it is possible for a child to fit into more than one diagnostic category
As the diagnostic nomenclature in the literature has been confusing and in a state of flux there are no data on the relative prevalence of various diagnoses, much less on the diagnostic categories used in the current classification. Consequently, we have minimal guidance for decisions relating to sample size; thus, the need for a pilot study. We believe that this study will allow us an insight into the frequency and variance in diagnosis of at least three of the major categories: children who are vigorous but with poor appetite, those who are highly selective, and those who are in fact misperceived to have a feeding problem. We also have no information on the feasibility and acceptance of the FDDT questionnaire and we believe the pilot study will facilitate our gaining the pediatrician's and office staff's perspective so that in future designs of the instrument we can overcome any practical limitations that become evident.
Design:
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. This study will be approximately one year in duration.
Data Collection:
The following data will be collected on study subjects as illustrated in the flow sheet on page 6 of this research protocol cover sheet.
- Historical data reported by the parent or guardian on the FDDT questionnaire
- The diagnosis suggested on the Cover sheet of the FDDT
- The pediatrician's details of the patient's physical examination, anthropometrics and calculations (weight and length or height percentiles and mid parental height). A prompt for these data is available in the FDDT. The patient's name will blacked out and a study subject number will be inserted.
- Data on the acceptance of the FDDT will be obtained from the office staff, the pediatricians, and the patients' parents.
- The diagnosis reached by the first feeding specialist (CPNP)
- The diagnosis reached by the second feeding specialist (Psychiatrist)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with overt, serious organic disease, including:
- Patients currently receiving parenteral or supplemental therapeutic enteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
3 secondary outcomes
Weight
Time frame: during wellness visit (1x) at enrollment
Height
Time frame: during wellness visit (1x) at enrollment
Growth Index
Time frame: during wellness visit (1x) at enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
Related trials for Feeding Difficulties
Active, not recruiting
Parent Tube Weaning Interviews
Feeding Difficulties, Remote Patient Monitoring
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Recruiting
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Dysphagia of Newborn
Enrolling by invitation
Effects of FEED@Home Intervention
Dementia, Dementia Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benny Kerzner, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Difficulties and Feeding and Eating Disorders of Childhood, run by Benny Kerzner, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.