Evidence map›Paper›PMID 33259163›Full record

Trial reportClinical and translational gastroenterology2020

Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial.

Sudarshan R Jadcherla, Kathryn A Hasenstab, Ish K Gulati, Roseanna Helmick, Haluk Ipek, Vedat Yildiz, Lai Wei

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

7 authors at 2 institutions in 1 country.

Sudarshan R JadcherlaInnovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA.
Kathryn A HasenstabInnovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA.
Ish K GulatiInnovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA.
Roseanna HelmickInnovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA.
Haluk IpekInnovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA.
Vedat YildizBiostatistics Resource at Nationwide Children's Hospital (BRANCH), Columbus, Ohio, USA.
Lai WeiCenter for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, Ohio, USA.
Nationwide Children's Hospital · USThe Ohio State University · US

Funding

The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve HealthUL1TR002733 · NCATS · OHIO STATE UNIVERSITY · PI RINGEL, MATTHEW D · 2018 to 2022
$28.9M
Pathophysiology of Aerodigestive Reflexes in InfantsR01DK068158 · NIDDK · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · PI JADCHERLA, SUDARSHAN R · 2006 to 2016
$3.7M
NCATS NIH HHS UL1 TR002733NIDDK NIH HHS R01 DK068158
6 · The paper itself

Abstract

introductionAims were to test hypothesis that esophageal provocation-induced reflexes are superior with acid suppression plus feeding modifications vs acid suppression alone among infants treated for gastroesophageal reflux disease (GERD).

methodsInfants (N = 49, 41.3 ± 2.6 of postmenstrual age) with acid reflux index >3% underwent longitudinal motility testing (weeks 0 and 5) with graded midesophageal provocation to test randomly allocated therapies (4 weeks' proton pump inhibitor [PPI] ± feeding modifications) on sensory-motor aerodigestive reflexes. Feeding modification included restricted fluid volume <140 mL/kg per day, fed over 30 minutes in right lateral position and supine postprandial position. Primary motility outcome was frequency-occurrence of peristaltic reflex. Secondary outcomes included upper esophageal sphincter contractile reflex, lower esophageal sphincter (LES) relaxation reflex, respiratory change, and symptom characteristics.

resultsTreatment groups did not differ for primary outcome (odds ratio = 0.8, 95% confidence interval 0.4-1.6, P = 0.99) or secondary outcomes (all P > 0.05). For both treatment groups at follow-up, distal esophageal contraction and LES tone decreased, and LES relaxation reflex occurrence is less frequent (all P < 0.05). In a subgroup analysis, comparing infants with PPI washout (N = 40) vs with continued (N = 9) PPI therapy, no differences were noted for aerodigestive reflex response frequency-occurrence (all P > 0.05). DISCUSSION: In infants with GERD, feeding modification with acid suppression is not superior to acid suppression alone in modifying aerodigestive reflexes (frequency, sensation, or magnitude). Contiguous areas targeted by GER, i.e., LES and distal esophageal functions, worsened at follow-up for both groups despite PPI therapy. Maturation is likely the key factor for GERD resolution in infants, justifying the use of placebo in clinical trials for objectively determined GERD.

Indexed as

EsophagusFeeding BehaviorFemaleFollow-Up StudiesGastroesophageal RefluxHumansInfantInfant, NewbornMaleOmeprazolePeristalsisPostprandial PeriodProton Pump InhibitorsReflexSupine PositionTreatment OutcomeOmeprazoleProton Pump Inhibitors

Identifiers

PMID33259163
PMCPMC7643906
OpenAlexW3097929995

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.