Evidence map›Paper›PMID 26947568›Full record

Trial reportThe Journal of pediatrics2016

A Randomized Controlled Trial of an Outpatient Protocol for Transitioning Children from Tube to Oral Feeding: No Need for Amitriptyline.

Ann M Davis, Kelsey Dean, Hayat Mousa, Sarah Edwards, Jose Cocjin, Osama Almadhoun, Jianghua He, Amanda Bruce, Paul E Hyman

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01206478 (A Phase II, Randomized-Controlled, Multicenter Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01206478 phase2completednot on this map

A Phase II, Randomized-Controlled, Multicenter Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

TypeinterventionalSponsorAnn Davis, PhD, MPH, ABPPRan2010 to 2014Enrolled21ConditionsChronic Oral Food RefusalArmsAmitriptyline, Placebo, Megestrol
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success.Journal of clinical psychology in medical settings · 2023
    Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Weaning children from prolonged enteral nutrition: A position paper.European journal of clinical nutrition · 2022
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
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.

Ann M DavisDepartment of Pediatrics, University of Kansas Medical Center, Kansas City, KS; Center for Children's Healthy Lifestyles and Nutrition, Kansas City, MO. Electronic address: Adavis6@kumc.edu.
Kelsey DeanCenter for Children's Healthy Lifestyles and Nutrition, Kansas City, MO.
Hayat MousaPediatric Gastroenterology, Hepatology and Nutrition Department, University of California San Diego/Rady Children's Hospital, San Diego, CA.
Sarah EdwardsPediatric Gastroenterology, Children's Mercy Kansas City, Kansas City, MO.
Jose CocjinPediatric Gastroenterology, Children's Mercy Kansas City, Kansas City, MO.
Osama AlmadhounDepartment of Pediatrics, University of Kansas Medical Center, Kansas City, KS.
Jianghua HeDepartment of Biostatistics, University of Kansas Medical Center, Kansas City, KS.
Amanda BruceDepartment of Pediatrics, University of Kansas Medical Center, Kansas City, KS; Center for Children's Healthy Lifestyles and Nutrition, Kansas City, MO.
Paul E HymanNew Orleans Children's Hospital, New Orleans, LA.

Funding

"A randomized controlled trial of amitriptyline for chronic oral food refusal" R21HD066629 · NICHD · UNIVERSITY OF KANSAS MEDICAL CENTER · PI DAVIS, ANN M · 2010 to 2011
$527k
NICHD NIH HHS R21 HD066629
6 · The paper itself

Abstract

objectiveTo assess the role of amitriptyline in the effectiveness of an outpatient protocol for weaning medically complicated children from tube to oral feeding. STUDY

designTwenty-one children seen in multidisciplinary outpatient feeding teams across 4 sites were recruited to a randomized placebo-controlled trial of a 6-month outpatient treatment protocol with behavioral, oral-motor, nutrition, and medication components.

resultsAll of the children who completed the 6-month program (73%) were weaned to receive only oral feeding, regardless of group assignment. The transition from tube to oral feeding resulted in decreases in body mass index percentile and pain, some improvements in quality of life, and no statistically significant changes in cost.

conclusionsAmitriptyline is not a key component of this otherwise effective outpatient, interdisciplinary protocol for weaning children from tube to oral feeding.

trial registrationClinicalTrials.gov: NCT01206478.

Indexed as

AmitriptylineAnalgesics, Non-NarcoticBody Mass IndexChildEnteral NutritionFeeding BehaviorFemaleHumansMaleNutritional StatusOutpatientsPainQuality of LifeWeaningAmitriptylineAnalgesics, Non-Narcotic

Identifiers

PMID26947568
PMCPMC4846510

What OpenQuestion holds

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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.