A Novel Orthotropic Pacifier to Reduce Nasal Obstruction in Neonates: A Pilot Study

Introduction: A high, narrow palate elevates nasal airway resistance yet is typically corrected only later in childhood with invasive rapid maxillary expansion. In the first longitudinal study of term infants from birth to six months, we tested whether daily use of a novel silicone orthotropic pacifier can safely lower the palatal index and furnish otolaryngologists with a non-invasive tool to mitigate early nasal obstruction and sleep-disordered breathing.

Methods: In this prospective single-center pilot, 28 full-term neonates aged ≤1 month were enrolled 04/2023–09/2024 from two Phoenix, AZ obstetrics/gynecology offices. All received the study pacifier; mean daily exposure (hours) was the independent variable, stratified as compliant (≥2 h) or high-use (≥6 h). Palatal index (PI = height/width), an anatomic marker of neonatal nasal obstruction, was derived from TRIOS® intra-oral scans at baseline, 3, and 6 months. Parents logged use, mucosal injury, and feeding interference. Repeated-measures ANOVA and Welch-corrected paired t-tests (α = 0.05) assessed within-subject PI change.

Results: 26 infants completed follow-up. Mean exposure was 2.22 ± 1.0 h/day (median 1.99); 19 compliant infants averaged 6.8 ± 1.4 h. No device-related adverse events occurred. From 0–3 months the compliant group showed ΔPI = +3.23 ± 8.46 versus +0.28 ± 6.16 (p = 0.315). From 0–6 months ΔPI was -0.13 ± 5.52 in compliant infants and +5.09 ± 6.20 in non-compliant infants (p = 0.036; Cohen d 0.92). Daily exposure correlated inversely with 6-month ΔPI (r = -0.50, p = 0.010).

Conclusions: Regular use of this orthotropic pacifier safely lowered PI within six months suggesting early, parent-directed palatal modulation may reduce pediatric sleep-disordered breathing. Larger controlled trials are warranted.