Background: The aim of this study was to evaluate the efficacy, safety profile, and complications associated with mandibular distraction osteogenesis performed in infants weighing less than 4 kg with Robin sequence. Methods: An 11-year retrospective review of all infants (younger than 6 months) with mandibular distraction osteogenesis-treated Robin sequence was performed. Patients weighing less than 4 kg (experimental) and 4 kg or more (control) who underwent mandibular distraction osteogenesis were compared. Demographics, medical comorbidities, improvement in apnea/hypopnea index, need for tracheostomy, repeated distraction, and complications were evaluated. Results: One hundred twenty-one patients underwent mandibular distraction osteogenesis. Eighty-one patients weighed less than 4 kg and 40 weighed 4 kg or more. The mean follow-up was 2.8 years in patients weighing less than 4 kg and 3.0 years in the control group. Mean age and weight at the time of distraction were 23 days and 3.1 kg, respectively, in the study group; and 2.7 years and 11 kg, respectively, in the control group. There was no significant difference in success of mandibular distraction osteogenesis to treat airway obstruction in the group weighing less than 4 kg compared with the control group (92.6 percent versus 88.9 percent; p = 0.49). The most common complication in each group was surgical-site infection (9.9 percent and 20.0 percent; p = 0.15). Overall complication rates were similar between the two groups (17.3 percent versus 25.0 percent; p = 0.34). The rates of repeated distraction were similar between the two groups (6.3 percent and 13.5 percent; p = 0.28). Conclusions: Mandibular distraction osteogenesis is a safe and effective treatment modality for infants weighing less than 4 kg with severe airway obstruction. The efficacy, safety, and complication profiles are not significantly different from those of larger patients.
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