Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Condition: Chronic Oral Food Refusal
Intervention: Amitriptyline; Placebo; Megestrol
Intervention description: Amitriptyline 1 mg/kg once daily at bedtime.; Placebo (looks like study drug but has no active ingredients) once daily at bedtime.; At 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.
Intervention MeSH terms: Megestrol; Amitriptyline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 9 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.