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Objective A new oral appliance to treat obstructive sleep apnea in infants with Pierre Robin sequence has recently been shown to be superior to a sham procedure. We now investigate safety and long-term effects of this appliance on obstructive sleep apnea in infants with Pierre Robin sequence. Design Case series with repetitive follow-up examinations. Setting Tertiary neonatal intensive care unit at the University Children's Hospital Tuebingen, Germany. Patients Fifteen infants (11 girls and four boys; median age, 5 days) with Pierre Robin sequence and obstructive sleep apnea (i.e., mixed-obstructive-apnea index > 3). Intervention A custom-made intraoral appliance with velar extension was used continuously in situ from admission until 3 months after hospital discharge. Main Outcome Measure The mixed-obstructive-apnea index was determined prior to the intervention at admission, at discharge, and 3 months later using polygraphic sleep studies. The geometric mean of the mixed-obstructive-apnea index and its 95% confidence interval were calculated. Results Compared with admission (mean, 17.2; 95% confidence interval, 11.1–26.7), there was a significant decrease in the mixed-obstructive-apnea index to discharge (mean, 3.8; 95% confidence interval, 2.2–6.6) and 3 months later (mean, 1.2; 95% confidence interval, 0.7–2.2; p value < .001). No severe adverse events occurred. Conclusions This oral appliance was safe and appears to treat obstructive sleep apnea effectively in infants with Pierre Robin sequence.