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

J Pediatr. 2007 Aug;151(2):145-9. doi: 10.1016/j.jpeds.2007.02.063. Epub 2007 Jun 22.

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).

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Airway Obstruction / etiology
  • Airway Obstruction / therapy*
  • Catheterization / instrumentation
  • Cross-Over Studies
  • Equipment Design
  • Equipment Safety
  • Female
  • Follow-Up Studies
  • Humans
  • Infant, Newborn
  • Male
  • Orthodontic Appliances / statistics & numerical data*
  • Pierre Robin Syndrome / complications*
  • Pierre Robin Syndrome / diagnosis
  • Quality of Life
  • Respiratory Function Tests
  • Risk Assessment
  • Sleep Apnea, Obstructive / etiology
  • Sleep Apnea, Obstructive / therapy*
  • Treatment Outcome