Status:
COMPLETED
Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Lead Sponsor:
Ann Davis, PhD, MPH, ABPP
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Chronic Oral Food Refusal
Eligibility:
All Genders
9-8 years
Phase:
PHASE2
Brief 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 m...
Detailed Description
This research study involves a study drugs called amitriptyline and megestrol. Amitriptyline might help children who have feeding problems with pain and megestrol is known to increase appetite. Amitri...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects must meet all of the following inclusion criteria:
- Males or females 9 months to 8 years 0 months 0 days of age.
- Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations.
- Subjects must possess the oral motor skills necessary for eating according to Table 1 in the Appendix.
- Subjects must possess behavioral skills necessary for mealtime according to Table 2 in the Appendix.
- 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.
- 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:
- Children on MAO inhibitors or who have thyroid problems will be excluded.
- Children with diabetes or adrenal insufficiency will be excluded.
- Children with known heart conduction abnormalities.
- Children taking tricyclic medications.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01206478
Start Date
August 1 2010
End Date
December 1 2014
Last Update
August 15 2016
Active Locations (3)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205