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

Title: Acid Suppression in Mild‐Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial
Authors: Shaffer, Amber D.; Balogun, Zainab; Tobey, Allison B. J.; Maguire, Raymond C.; Simons, Jeffrey P.; Dohar, Joseph E.; Mccoy, Jennifer L.; Rushchak, Marina V.; Padia, Reema
Contributors: National Institutes of Health
Source: The Laryngoscope ; ISSN 0023-852X 1531-4995
Publisher Information: Wiley
Publication Year: 2025
Collection: Wiley Online Library (Open Access Articles via Crossref)
Description: Objective To 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. Methods From 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. Results Sixty‐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. Conclusion This 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 Registration https://clinicaltrials.gov/study/NCT04614974
Document Type: article in journal/newspaper
Language: English
DOI: 10.1002/lary.32471
Availability: https://doi.org/10.1002/lary.32471; https://onlinelibrary.wiley.com/doi/pdf/10.1002/lary.32471
Rights: http://creativecommons.org/licenses/by/4.0/
Accession Number: edsbas.3B4BD6FB
Database: BASE