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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Counseling in Combination with Behavioral Counseling | Experimental | Participants in the group will receive nutritional and behavioral counseling for up to 6 months |
|
| Cyproheptadine | Experimental | Participants in this group will receive the Cyproheptadine for up to 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproheptadine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 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. | Baseline and up to 6 months |
| Change in Child Food Neophobia score | Score of 10-70 with higher score indicating higher neophobia. | Baseline and up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Weight measured in kilograms | Baseline and up to 6 months |
| Change in height | Height measured in centimeters | Baseline and up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Saps, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Department of Pediatric Gastroenterology | Miami | Florida | 30345 | United States |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D015596 | Nutrition Assessment |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Nutritional Counseling | Behavioral | 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. |
|
| Behavioral Counseling | Behavioral | 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. |
|
| Change in BMI | BMI measured in kg/m2 | Baseline and up to 6 months |
| Change in BMI percentile | BMI measured in percent | Baseline and up to 6 months |
| Change in BMI Z-score | BMI measured in standard deviation units | Baseline and up to 6 months |
| Number of treatment related adverse events | 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. | 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. | Up to 6 months |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |