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Randomized Controlled Trial of a Car Safety Seat Insert to Reduce Hypoxia in Term Infants

OBJECTIVE: To test the hypothesis that a foam plastic insert that allows the infant head to rest in a neutral position in sleep may prevent obstruction of the upper airway and thus reduce episodes of reduced oxygenation in term infants in car seats. METHODS: Healthy full-term babies were randomized to be studied during sleep while restrained in an infant car safety seat either with or without the insert, with continuous polysomnographic recordings with sleep video. RESULTS: Seventy-eight infants (39 in each group) had polysomnogram recordings at a mean of 8 days of age. Both groups showed a small fall in mean hemoglobin oxygen saturation (SpO2) over the first hour of sleep. There was no difference between insert and no insert in the rate of moderate desaturations (a fall in SpO2 ≥4% lasting for ≥10 seconds, mean ± SEM, 17.0 ± 1.5 vs 17.2 ± 1.5/hour), or mean SpO2 during sleep. The insert was associated with a significant reduction in the rate of obstructive apnea (0.3 ± 0.1 vs 0.9 ± 1.5/hour, P < .03), the severity of desaturation events (minimum SpO2 82% ± 1% vs 74% ± 2%, P < .001), and time with SpO2 <85% (0.6% ± 0.3% vs 1.8% ± 1.4%, P = .03). CONCLUSIONS: In full-term newborn infants, a car seat insert that helps the head to lie in a neutral position was associated with reduced severity of desaturation events but not the overall rate of moderate desaturations.