Acid Suppression in Mild-Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial
Abstract
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)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 343 participants or records.
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