Pediatric Feeding Disorder, Chronic, Avoidant Restrictive Food Intake Disorder
Conditions
Keywords
Cyproheptadine, Malnutrition
Brief summary
The goal of this clinical trial is to learn if Cyproheptadine, an appetite stimulant, can improve eating habits in children with Pediatric Feeding Disorders. Pediatric Feeding Disorders is a broad term that describes disorders of eating-related behaviors that causes altered consumption of food and impairs physical or psychosocial health.
Interventions
DRUGCyproheptadine
Initiation of Cyproheptadine at 0.25mg/kg once daily by mouth at bedtime and titration up to at most three times daily as per participant's primary gastroenterologist.
BEHAVIORALNutritional Counseling
This includes in person counseling by a provider once in office for up to 15 minutes as well as standardized hand out with basic nutritional guidance on high-calorie foods.
BEHAVIORALBehavioral Counseling
This includes in person counseling by a provider once in office for up to 15 minutes as well as standardized hand out with basic behavioral guidance.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinic with complaint of "poor weight gain, malnutrition, failure to thrive/weight faltering, picky eating, or feeding issues" who screens positive for a pediatric feeding disorder using the Child eating disorder questionnaire (CEBQ) * Age Range: 2-6 years * English or Spanish speaking
Exclusion criteria
* Patients who are tube fed * Patients who are overweight (BMI at 85th%tile or greater) * Patients who have active symptoms from a diagnosis of a GI disorder (Inflammatory Bowel Disease, Eosinophilic Esophagitis, Gastritis) * Patients actively undergoing behavioral feeding therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children's Eating Behavior Questionnaire score | Baseline and up to 6 months | A composite score will be obtained and scores range from 1-5 with higher scores indicating more behavioral eating. |
| Number of foods consumed by participants | Baseline and up to 6 months | Number of food consumed will be collected. Number of foods consumed as defined as eaten more than once per month. |
| Change in Child Food Neophobia score | Baseline and up to 6 months | Score of 10-70 with higher score indicating higher neophobia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Baseline and up to 6 months | Weight measured in kilograms |
| Change in height | Baseline and up to 6 months | Height measured in centimeters |
| Change in BMI | Baseline and up to 6 months | BMI measured in kg/m2 |
| Change in BMI percentile | Baseline and up to 6 months | BMI measured in percent |
| Change in BMI Z-score | Baseline and up to 6 months | BMI measured in standard deviation units |
| Number of treatment related adverse events | Up to 6 months | Number of treatment related adverse events using the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5 as per physician discretion. |
| Parent's perception of medication's effects | Up to 6 months | Measured by Cyproheptadine Survey given to parents in yes/no format. Total sum of yes and no answers will be collected. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiguel Saps, MD
University of Miami
Outcome results
None listed