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

Buchenau W, Urschitz MS, Sautermeister J, Bacher M, Herberts T, Arand J, Poets CF

Department of Neonatology, University Hospital Tuebingen, Tuebingen, Germany.

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). STUDY DESIGN: Eleven 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. RESULTS: Compared 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. CONCLUSION: This new orthodontic appliance appears to be safe and effective in reducing upper airway obstruction in infants with PRS.

Published 23 July 2007 in J Pediatr, 151(2): 145-9.
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