iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children (iKanEat)
Feeding Behavior, Feeding Disorder of Infancy or Early Childhood
About this trial
This is an interventional treatment trial for Feeding Behavior focused on measuring Gastrostomy Tube, G-Tube, Oral Food Refusal, Behavioral Intervention, Megestrol, Transition to Oral Feedings, Weaning
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 9 months to 9y0m at the time of consent.
- Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations.
- Subjects must have a G or G/J tube.
- Subjects must receive over 80% of their total daily calorie needs from a tube in order to be classified as tube dependent.
- Subjects must have a ≥ 3 month history of feeding problems as identified by a diagnosis from a multidisciplinary feeding team, and must have permission from the physician on the team to ensure that they are medically stable enough to participate in a weaning study.
- Subjects must possess the oral motor skills necessary for eating. Subjects must possess behavioral skills necessary for mealtimes.
Exclusion Criteria:
- Children receiving oral or inhaled steroids.
- Parent has a known developmental delay or cognitive impairment that may make participation in the study difficult (children with these issues will not be excluded).
- Children receiving intensive (defined as more than one session per month) behavioral feeding therapy with a licensed psychologist (previous behavioral feeding therapy is not an exclusion criterion; neither is current oral-motor, sensory, or speech therapy).
- Children of non-English speaking parents.
Sites / Locations
- Rady Children's Hospital - San DiegoRecruiting
- Arnold Palmer Hospital for ChildrenRecruiting
- Riley Hospital for Children at IU HealthRecruiting
- Boston Children's HospitalRecruiting
- Children's Mercy HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Rhode Island HospitalRecruiting
- Monroe Carell Jr. Children's Hospital at VanderbiltRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Megestrol
Placebo
Megestrol is a steroid and progestational drug FDA approved for treating anorexia or weight loss in patients with acquired immunodeficiency syndrome. Its use in the current protocol is "off label" to stimulate appetite in tube-fed infants and toddlers who are weaning from tube feedings and learning to eat. The precise mechanism of action that leads to increased appetite and weight gain is unknown, but is probably related to megestrol's glucocorticoid effect. The proposed study will use megestrol 6 mg/kg/day in two doses because this dose has been effective and safe in two previous studies using megestrol to stimulate appetite in children transitioning from tube to oral feedings. The megestrol will be dosed at full dose weeks 10-11, at 66% dose week 12, at 33% dose week 14, and fully tapered at the end of week 14. Megestrol is absorbed from the small bowel, so feeding it through the tube will be acceptable.
Subjects randomized to the placebo protocol will receive a placebo syrup identical in taste and smell to megestrol at the same intervals as those in the megestrol group but the syrup will contain no active ingredients.