Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ann Davis, PhD, MPH, ABPP
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Megestrol; Megestrol Acetate

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.