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) 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 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.

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.