# The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditions

> **NIH NIH R01** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2020 · $435,421

## Abstract

Project Summary/Abstract
 Feeding problems requiring medical intervention occur in 3-10% of children. In addition, severe feeding
problems occur in 40-70% of children with chronic medical conditions. Gastrostomy (G-) and gastrojejunal (G-
J) tube feeding requirements may persist for months or years resulting in chronic oral food refusal. As the
prevalence of gastrostomy tube feeding has increased, so have the challenges associated with managing a
child with tube feeding and transitioning a child from tube to oral feeding. Previous research on transitioning
children from tube to oral feeding indicates that most programs are inpatient or day treatment, and many
children are not successful.
 Our team developed a novel interdisciplinary outpatient protocol for transitioning children from tube to
oral feeding called iKanEat. Data indicate iKanEat is effective for transitioning tube fed children to oral eating.
iKanEat results in statistically significant and clinically meaningful increases in oral eating. iKanEat is
composed of several key components, including two medications – amitriptyline and megesterol. However, our
most recent work (HD066629) suggests that amitriptyline is not a necessary component of the protocol, as all
children who completed the protocol consumed 100% of their calories orally at post treatment regardless of
receiving amitriptyline or placebo. The current proposal is a randomized controlled trial of the second
medication (megesterol) compared to placebo, to determine if megesterol improves the effectiveness of the
iKanEat protocol. As all medications have side effects, it is critical we determine if the benefits of megesterol as
part of iKanEat outweigh the risks of the medication.
 The primary aim of the current study is to conduct a randomized controlled trial of megesterol, the only
remaining medication that is part of the iKanEat protocol. The second aim is to assess the safety of megesterol
as part of the iKanEat protocol. Our previous work (as well as work by others) suggests that a 6 week course
of megesterol can lead to adrenal insufficiency in some children, so as part of the current protocol we will
assess the safety of a 4 week course of this drug.
 Finally, parents of tube fed children encounter multiple psychosocial stressors regarding tube feeding.
These include concerns about their child’s survival due to their underlying medical issues, feelings of “failure”
due to their inability to feed their child orally, increased feelings of stress around the tube feeding, and
decreased support from others due to the tube feeding. Our research indicates that quality of life is poor in tube
fed children, even more so than children with cancer or burns. Given the significance of these issues, the third
aim of the study is to examine the effect of the transition from tube to oral feeding on parent stress and parent
and child quality of life.

## Key facts

- **NIH application ID:** 9944653
- **Project number:** 5R01HD093933-03
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** Ann M Davis
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $435,421
- **Award type:** 5
- **Project period:** 2018-09-13 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9944653

## Citation

> US National Institutes of Health, RePORTER application 9944653, The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditions (5R01HD093933-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9944653. Licensed CC0.

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