Chronic Oral Food Refusal | Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Chronic Oral Food Refusal research study
What is the primary objective of this study?
Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or are unable to eat enough to have normal growth. Although often intended as temporary short-term solutions to medical complications, feeding tubes can become a permanent method for eating. While tube feeding routinely saves the lives of children who have long term food refusal, continuation of tube feeding can be hard for patients, caregivers, and families. At the current time there are few treatments for helping children move from tube to oral feeding. Some patients may be treated with the help of inpatient programs such as a combination of medical and behavioral techniques to train children to eat orally. These programs typically require hospital stays of 2-4 months. By doing the current study the investigators hope to learn if the investigational drug amitriptyline is helpful in moving children from tube to oral feeding, and to look at whether or not the treatment of pain helps with this transition.
Who is eligible to participate?
Inclusion Criteria Subjects must meet all of the following inclusion criteria: 1. Males or females 9 months to 8 years 0 months 0 days of age. 2. Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations. 3. Subjects must possess the oral motor skills necessary for eating according to Table 1 in the Appendix. 4. Subjects must possess behavioral skills necessary for mealtime according to Table 2 in the Appendix. 5. Subjects must have a history of chronic oral food refusal (3 months of refusing to eat more than 5% of their caloric intake orally) and be fed >95% of their caloric intake through a gastrostomy tube for 3 months or longer. 6. Subjects will be required to have a body mass index for age/gender of 25% or greater prior to beginning the protocol to ensure that subjects are sufficiently nourished. Exclusion Criteria Study enrollment will exclude potential subjects with any of the following conditions or taking any of the following medication: 1. Children on MAO inhibitors or who have thyroid problems will be excluded. 2. Children with diabetes or adrenal insufficiency will be excluded. 3. Children with known heart conduction abnormalities. 4. Children taking tricyclic medications.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Oral Food Refusal
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AmitriptylineAmitriptyline 1 mg/kg once daily at bedtime.
Drug:PlaceboPlacebo (looks like study drug but has no active ingredients) once daily at bedtime.
Drug:MegestrolAt Visit 2, after participating in the study for ten weeks, children will receive a prescription for the appetite stimulant megestrol. The dose each child will receive depends on their age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Amitriptyline plus MegestrolAmitriptyline once daily at bedtime plus megestrol starting at visit 2
Placebo plus MegestrolMatching placebo once daily at bedtime plus megestrol starting at visit 2
Start Date: August 2010
Completed Date: December 2014
Phase: Phase 2
Primary Outcome: % Calories Taken Orally
Secondary Outcome: Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores
Study sponsors, principal investigator, and references
Principal Investigator: Ann Davis, Ph.D., MPH, ABPP
Lead Sponsor: Ann Davis, PhD, MPH, ABPP
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)