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

Objective To 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. Design Randomised controlled trial. Setting Family homes in low socio-economic areas in New Zealand. Patients 200 mainly Māori mothers and their infants. Interventions Participants received a wahakura or bassinet from birth. Main outcome measures Overnight oximetry, heart rate and temperature at 1 month. Results Intention-to-treat analysis for 83 bassinet and 84 wahakura infants showed no significant differences between groups for the mean time oxygen saturation (SpO 2 ) 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 SpO 2 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 Conclusions This 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 number Australian New Zealand Clinical Trials Registry: ACTRN12610000993099.