Physiological stability in an indigenous sleep device: a randomised controlled trial

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ObjectiveTo compare overnight oxygen saturation, heart rate and the thermal environment of infants sleeping in an indigenous sleep device (wahakura) or bassinet to identify potential risks and benefits.DesignRandomised controlled trial.SettingFamily homes in low socio-economic areas in New Zealand.Patients200 mainly Māori mothers and their infants.InterventionsParticipants received a wahakura or bassinet from birth.Main outcome measuresOvernight oximetry, heart rate and temperature at 1 month.ResultsIntention-to-treat analysis for 83 bassinet and 84 wahakura infants showed no significant differences between groups for the mean time oxygen saturation (SpO2) was less than 94% (0.54 min, 95% CI -1.36 to 2.45) or less than 90% (0.22 min, 95% CI -0.56 to 1.00), the mean number of SpO2 dips per hour >5% (-0.19, 95% CI -3.07 to 2.69) or >10% (-0.41, 95% CI -1.63 to 0.81), mean heart rate (1.99 beats/min, 95% CI -1.02 to 4.99), or time shin temperature >36°C (risk ratio (RR): 0.63, 95% CI 0.13 to 2.99) or <34°C (RR: 0.89, 95% CI 0.61 to 1.30). A per-protocol analysis of 45 bassinet and 26 wahakura infants and an as-used analysis of 104 infants in a bassinet and 48 in a wahakura found no significant differences between groups for all outcome measures.ConclusionsThis indigenous sleep device is at least as safe as the currently recommended bassinet, which supports its use as a sleep environment that offers an alternative way of bed-sharing.Trial registration numberAustralian New Zealand Clinical Trials Registry: ACTRN12610000993099.

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