Evidence map›Paper›PMID 33640012›Full record

ArticleTrials2021

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol.

Sarah Edwards, Paul E Hyman, Hayat Mousa, Amanda Bruce, Jose Cocjin, Kelsey Dean, Kandace Fleming, Rebecca Swinburne Romine, Ann M Davis

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03815019 (iKanEat), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03815019 phase4completednot on this map

iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children 9 Months to 9 Years 0 Months of Age

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2019 to 2025Enrolled70ConditionsFeeding Behavior, Feeding Disorder of Infancy or Early ChildhoodArmsMegestrol Acetate, iKanEat Behavioral Intervention
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success.Journal of clinical psychology in medical settings · 2023
    Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Sarah EdwardsPediatric Gastroenterology, Children's Mercy Kansas City, Kansas City, MO, USA.ORCID http://orcid.org/0000-0001-5504-4738
Paul E HymanPediatric Gastroenterology, New Orleans Children's Hospital, New Orleans, LA, USA.
Hayat MousaPediatric Gastroenterology, Hepatology and Nutrition, University of California San Diego/Rady Children's Hospital, San Diego, CA, USA.
Amanda BruceDepartment of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS, 66160, USA.
Jose CocjinPediatric Gastroenterology, Children's Mercy Kansas City, Kansas City, MO, USA.
Kelsey DeanDepartment of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS, 66160, USA.
Kandace FlemingLife Span Institute, University of Kansas, Lawrence, KS, USA.
Rebecca Swinburne RomineLife Span Institute, University of Kansas, Lawrence, KS, USA.
Ann M DavisDepartment of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS, 66160, USA. adavis6@kumc.edu.
Center for Children · USChildren's Mercy Hospital · USUniversity of Kansas · USChildren's Hospital of New Orleans · USUniversity of California San Diego · US

Funding

The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditionsR01HD093933 · NICHD · UNIVERSITY OF KANSAS MEDICAL CENTER · PI DAVIS, ANN M · 2018 to 2023
$2.2M
National Institutes of Health (US) NIH 1R01HD093933NICHD NIH HHS R01 HD093933
6 · The paper itself

Abstract

backgroundAlthough tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the best methods for weaning children from their feeding tubes.

methodsThe current paper describes a randomized controlled trial of an empirically supported outpatient treatment protocol for moving children from tube to oral eating called iKanEat. Specifically, we describe the methods of randomized double-blind, placebo-controlled trial which includes a 4-week course of megestrol, the only medication used in the iKanEat protocol, to determine whether the addition of megestrol results in improved child outcomes. The primary and secondary aims are to assess the safety and efficacy of megestrol as part of the iKanEat protocol. The third aim is to provide critical information about the impact of the transition from tube to oral feeding on parent stress and parent and child quality of life. DISCUSSION: This trial will provide data regarding whether megestrol is a safe and effective component of the iKanEat tube weaning protocol, as well as important data on how the tube weaning process impacts parent stress and parent and child quality of life.

trial registrationClinicalTrials.gov NCT#03815019 . Registered on January 17, 2019.

Indexed as

MegestrolQuality of LifeChildDouble-Blind MethodEnteral NutritionHumansRandomized Controlled Trials as TopicTreatment OutcomeWeaningMegestrolFeeding problemsMegestrolRandomized controlled trialTube feedingTube weaning

Identifiers

PMID33640012
PMCPMC7913389
OpenAlexW3133543913

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.