title: A randomized clinical trial of a new orthodontic appliance to improve upper airway obstruction in infants with Pierre Robin sequence.
abstract: 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.
authors.affiliation: Department of Neonatology, University Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Buchenau
authors.forename: Michael S
authors.initials: MS
authors.lastname: Urschitz
authors.forename: Judit
authors.initials: J
authors.lastname: Sautermeister
authors.forename: Margit
authors.initials: M
authors.lastname: Bacher
authors.forename: Tina
authors.initials: T
authors.lastname: Herberts
authors.forename: Joerg
authors.initials: J
authors.lastname: Arand
authors.forename: Christian F
authors.initials: CF
authors.lastname: Poets
mesh_terms: 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