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).


METHODS
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.


CONCLUSIONS
This new orthodontic appliance appears to be safe and effective in reducing upper airway obstruction in infants with PRS.
Buchenau
Wolfgang
W
Department of Neonatology, University Hospital Tuebingen, Tuebingen, Germany.
Urschitz
Michael S
MS
Sautermeister
Judit
J
Bacher
Margit
M
Herberts
Tina
T
Arand
Joerg
J
Poets
Christian F
CF
D000402:Airway Obstruction / Q000209:etiology / Q000628:therapy*; D002404:Catheterization / Q000295:instrumentation; D018592:Cross-Over Studies; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009967:Orthodontic Appliances / Q000706:statistics & numerical data*; D010855:Pierre Robin Syndrome / Q000150:complications* / Q000175:diagnosis; D011788:Quality of Life; D012129:Respiratory Function Tests; D018570:Risk Assessment; D020181:Sleep Apnea, Obstructive / Q000209:etiology / Q000628:therapy*; D016896:Treatment Outcome