A randomized clinical trial of a new orthodontic appliance to improve upper airway obstruction in infants with Pierre Robin sequence.

Objective To 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). Studydesign Eleven infants with PRS (median age, 3 days) and an apnea index (Al) >3 were studied. The effect of the new appliance on the Al was compared with that of a conventional appliance without a velar extension by using a crossover study design with random allocation. Results Compared with baseline (mean boolean AND l, 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 At was -71% (95% Cl, -84--49) for the new appliance and,+8% (95% C1, -52-142) for the conventional appliance, which was significantly different (P =.004). No severe adverse effects were observed. Conclusion This new orthodontic appliance appears to be safe and effective in reducing upper airway obstruction in infants with PRS.