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

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.

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.

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.

This small randomized controlled trial was unable to demonstrate additional benefit from AST compared to feeding modifications alone based on airway and reflux symptoms.

https://clinicaltrials.gov/study/NCT04614974.