A Randomized Clinical Trial of a New Orthodontic Appliance to Improve Upper Airway Obstruction in Infants with Pierre Robin Sequence

ObjectiveTo test the hypothesis that a new orthodontic appliance with a velar extension that shifts the tongue anteriorly would reduce upper airway obstruction in infants with Pierre Robin sequence (PRS).Study designEleven infants with PRS (median age, 3 days) and an apnea index (AI) >3 were studied. The effect of the new appliance on the AI was compared with that of a conventional appliance without a velar extension by using a crossover study design with random allocation.ResultsCompared with baseline (mean AI, 13.8), there was a significant decrease in the AI with the new appliance (3.9; P value <.001), but no change with the conventional appliance (14.8; P = .842). Thus, the relative change in AI was −71% (95% CI, −84-−49) for the new appliance and +8% (95% CI, −52-142) for the conventional appliance, which was significantly different (P = .004). No severe adverse effects were observed.ConclusionThis new orthodontic appliance appears to be safe and effective in reducing upper airway obstruction in infants with PRS.