Tipene-Leach David, Baddock Sally, Williams Sheila, Jones Raymond, Tangiora Angeline, Abel Sally, Taylor Barry
Women's and Children's Health, Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand.
BMC Pediatr. 2014 Sep 28;14:240. doi: 10.1186/1471-2431-14-240.
Sudden Unexpected Death in Infancy (SUDI) has persistent high rates in deprived indigenous communities and much of this mortality is attributable to unsafe sleep environments. Whilst health promotion worldwide has concentrated on avoidance of bedsharing, the indigenous Māori community in New Zealand has reproduced a traditional flax bassinet (wahakura) designed to be used in ways that include bedsharing. To date there has been no assessment of the safety of this traditional sleeping device.
METHODS/DESIGN: This two arm randomised controlled trial is being conducted with 200 mother-baby dyads recruited from Māori communities in areas of high deprivation in the Hawkes Bay, New Zealand. They are randomised to wahakura or bassinet use and investigation includes questionnaires at baseline (pregnancy), when baby is 1, 3, and 6 months, and an overnight video sleep study at 1 month with monitoring of baby temperature and oxygen saturation, and measurement of baby urinary cotinine and maternal salivary oxytocin. Outcome measures are amount of time head covered, amount of time in thermal comfort zone, number of hypoxic events, amount of time in the assigned sleep device, amount of time breastfeeding, number of parental (non-feed related) touching infant events, amount of time in the prone sleep position, the number of behavioural arousals and the amount of time infant is awake overnight. Survey data will compare breastfeeding patterns at 1, 3, and 6 months as well as data on maternal mind-mindedness, maternal wellbeing, attachment to baby, and maternal sleep patterns.
Indigenous communities require creative SUDI interventions that fit within their prevailing world view. This trial, and its assessment of the safety of a wahakura relative to a standard bassinet, is an important contribution to the range of SUDI prevention research being undertaken worldwide.
Australian New Zealand Clinical Trials Registry: ACTRN12610000993099 Registered 16th November 2010.
婴儿猝死综合征（SUDI）在贫困的原住民社区中一直保持着较高的发生率，其中很大一部分死亡率可归因于不安全的睡眠环境。尽管全球范围内的健康促进活动都集中在避免同床共眠，但新西兰的毛利原住民社区重新制作了一种传统的亚麻摇篮（瓦哈库拉），其设计用途包括同床共眠。迄今为止，尚未对这种传统睡眠设备的安全性进行评估。
方法/设计：这项双臂随机对照试验正在新西兰霍克斯湾高贫困地区的毛利社区招募200对母婴。他们被随机分配使用瓦哈库拉或摇篮，调查内容包括基线（孕期）、婴儿1个月、3个月和6个月时的问卷，以及1个月时的夜间视频睡眠研究，监测婴儿体温和血氧饱和度，并测量婴儿尿可替宁和母亲唾液催产素。结局指标包括头部覆盖时间、热舒适区时间、缺氧事件数量、在指定睡眠设备中的时间、母乳喂养时间、父母（非喂食相关）触摸婴儿事件数量、俯卧睡眠姿势时间、行为觉醒次数以及婴儿夜间清醒时间。调查数据将比较1个月、3个月和6个月时的母乳喂养模式，以及关于母亲心智化、母亲幸福感、与婴儿的依恋关系和母亲睡眠模式的数据。
原住民社区需要符合其主流世界观的创新性SUDI干预措施。这项试验及其对瓦哈库拉相对于标准摇篮安全性的评估，是对全球正在进行的一系列SUDI预防研究的重要贡献。
澳大利亚新西兰临床试验注册中心：ACTRN12610000993099 于2010年11月16日注册。
