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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
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.
University of Miami Department of Pediatric Gastroenterology
Miami, Florida, United States
RECRUITINGChange in Children's Eating Behavior Questionnaire score
A composite score will be obtained and scores range from 1-5 with higher scores indicating more behavioral eating.
Time frame: Baseline and up to 6 months
Number of foods consumed by participants
Number of food consumed will be collected. Number of foods consumed as defined as eaten more than once per month.
Time frame: Baseline and up to 6 months
Change in Child Food Neophobia score
Score of 10-70 with higher score indicating higher neophobia.
Time frame: Baseline and up to 6 months
Change in weight
Weight measured in kilograms
Time frame: Baseline and up to 6 months
Change in height
Height measured in centimeters
Time frame: Baseline and up to 6 months
Change in BMI
BMI measured in kg/m2
Time frame: Baseline and up to 6 months
Change in BMI percentile
BMI measured in percent
Time frame: Baseline and up to 6 months
Change in BMI Z-score
BMI measured in standard deviation units
Time frame: Baseline and up to 6 months
Number of treatment related adverse events
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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.
Time frame: Up to 6 months
Parent's perception of medication's effects
Measured by Cyproheptadine Survey given to parents in yes/no format. Total sum of yes and no answers will be collected.
Time frame: Up to 6 months