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 (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.
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.
- sudden infant death syndrome
- oxygen saturation
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Contributors SB participated in the design and coordination of the study, conception of the data analysis, contributed to the funding application, led the drafting of the manuscript and approved the final manuscript as submitted. DTL was responsible for the initial concept, participated in the design and coordination of the study, contributed to the funding application, helped edit the manuscript and approved the final manuscript as submitted. SMW participated in the design, and coordination of the study, completed the statistical analysis, helped edit the manuscript and approved the final manuscript as submitted. RJ and AT both participated in the design and coordination of the study, helped edit and approved the final manuscript as submitted. AKM helped with data analysis, participated in drafting of the manuscript and approved the final manuscript as submitted. BJT participated in the conception and design of the study, obtained the funding, is the guarantor for the study, helped edit the manuscript and approved the final manuscript as submitted.
Funding Funding was obtained from the Health Research Council of New Zealand (grant ref 10/477) and a University of Otago Research Grant. The funders had no role in the study design, or in the collection, analysis and interpretation of data, or in the writing of the report or the decision to submit the article for publication.
Competing interests None declared.
Patient consent Custom prepared consent forms, approved by the New Zealand Central Region Ethics Committee (CEN/10/12/054), were signed by the mothers.
Ethics approval The New Zealand Central Region Ethics Committee (CEN/10/12/054)
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Behavioral data from the same infants were published in: Baddock S, Tipene-Leach D, Williams S et al. Wahakura versus bassinet for safe infant sleep: a randomized trial. Pediatrics 2017;139:e20160162–0160162. The corresponding author can be contacted with respect to datafiles.
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