Evidence map›Paper›PMID 40762274›Full record

Trial reportThe Laryngoscope2026

Acid Suppression in Mild-Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial.

Amber D Shaffer, Zainab Balogun, Allison B J Tobey, Raymond C Maguire, Jeffrey P Simons, Joseph E Dohar, Jennifer L Mccoy, Marina V Rushchak, Reema Padia

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Laryngoscope, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04614974 (Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT04614974 phase1 / phase2terminatednot on this map

Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia

TypeinterventionalSponsorReema PadiaRan2020 to 2024Enrolled65ConditionsLaryngomalacia, Gastro Esophageal RefluxArmsFamotidine, Speech Language Therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
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.

Amber D ShafferDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-5783-9198
Zainab BalogunDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Allison B J TobeyDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Raymond C MaguireDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Jeffrey P SimonsDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-6378-0281
Joseph E DoharDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Jennifer L MccoyDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0003-2217-4493
Marina V RushchakDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Reema PadiaDepartment of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-5876-7816

Funding

NIH HHS UL1-TR-001857
6 · The paper itself

Abstract

objectiveTo determine the efficacy of acid suppression therapy (AST) for the treatment of gastroesophageal reflux (GER) and airway symptoms in infants with mild to moderate laryngomalacia.

methodsFrom 2020 to 2023, infants ≤ 6 months old with laryngomalacia at a tertiary children's hospital were randomized to famotidine and feeding modifications (AST) or feeding modifications alone (no-AST). Laryngomalacia Airway Symptom Score (LASS) and Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) were completed by guardians. Of 343 patients approached, 257 were excluded due to severe laryngomalacia on LASS, severe GER (I-GERQ-R ≥ 16), prior AST, no laryngomalacia on laryngoscopy, recommendation for supraglottoplasty, and/or other airway anomalies. Twenty-one declined participation. LASS and I-GERQ-R were again completed 1-6 months following enrollment.

resultsSixty-five patients enrolled; 40/65 (62%) followed up at a mean of 3.1 months (SD 1.4 months). Of these 40, 10 (25%) had mild and 30 (75%) had moderate laryngomalacia. Median I-GERQ-R was 11 (range 5-15) at the initial appointment and 7.5 (range 0-26) at follow-up (p = 0.002). Laryngomalacia resolved in 13/40 (33%) at follow-up based on LASS (p < 0.001). Patients randomized to AST (n = 20) and no-AST (n = 20) had comparable improvement on LASS (p = 0.3) and I-GERQ-R (p = 0.8). Additionally, the severity of laryngomalacia at initial consult did not have a significant impact on LASS (p = 0.3) or I-GERQ-R (p = 0.8) improvement. LASS (ρ = 0.423, p = 0.007) but not I-GERQ-R (ρ = 0.122, p = 0.5) improved more with longer time from consult to follow-up.

conclusionThis small randomized controlled trial was unable to demonstrate additional benefit from AST compared to feeding modifications alone based on airway and reflux symptoms. LEVEL OF EVIDENCE: 2:

trial registrationhttps://clinicaltrials.gov/study/NCT04614974.

Indexed as

Gastroesophageal RefluxLaryngomalaciaClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleHumansInfantMaleSeverity of Illness IndexTreatment Outcomefamotidineinfantlaryngomalaciastridor

Identifiers

PMID40762274
PMCPMC12770870

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.