Moon Rachel Y, Hauck Fern R, Colson Eve R, Kellams Ann L, Geller Nicole L, Heeren Timothy, Kerr Stephen M, Drake Emily E, Tanabe Kawai, McClain Mary, Corwin Michael J
Department of Pediatrics, School of Medicine, University of Virginia, Charlottesville.
Department of Family Medicine, School of Medicine, University of Virginia, Charlottesville.
JAMA. 2017 Jul 25;318(4):351-359. doi: 10.1001/jama.2017.8982.
Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths.
To assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions.
DESIGN, SETTING, AND PARTICIPANTS: Four-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016.
All participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices.
The primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days.
Of the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position.
Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied.
clinicaltrials.gov Identifier: NCT01713868.
未能充分遵循已知可降低婴儿意外猝死风险的建议，导致此类死亡人数下降趋势放缓。
评估两种干预措施单独及联合使用时，与对照干预措施相比，在促进婴儿安全睡眠习惯方面的有效性。
设计、背景和参与者：对健康足月儿母亲进行的四组整群随机临床试验。这些母亲于2015年3月至2016年5月在美国16家年分娩量超过100例的医院招募。数据收集于2016年10月结束。
所有参与者均受益于一项关于婴儿安全睡眠习惯（干预组）或母乳喂养（对照组）的护理质量改进活动，然后接受一项为期60天的移动健康计划，在此期间，母亲们会收到频繁的电子邮件或短信，其中包含有关婴儿安全睡眠习惯（干预组）或母乳喂养（对照组）的教育内容短视频以及关于婴儿护理习惯的询问。
主要结局是母亲自我报告对4种婴儿安全睡眠习惯的遵循情况，即睡眠姿势（仰卧）、睡眠地点（同室不同床）、使用柔软床上用品（不使用）和使用安抚奶嘴（任何情况）；当婴儿60至240日龄时，通过母亲调查收集数据。
在随机分为4组（每组400人）的1600名母亲中，1263人完成了调查（78.9%）。母亲的平均（标准差）年龄为28.1岁（5.8岁），32.8%的受访者为非西班牙裔白人，32.3%为西班牙裔，27.2%为非西班牙裔黑人，7.7%为其他种族/族裔。婴儿的平均（标准差）年龄为11.2周（4.4周），51.2%为女性。在调整分析中，与接受对照移动健康干预的母亲相比，接受安全睡眠移动健康干预的母亲让婴儿仰卧的比例更高（分别为89.1%和80.2%；调整风险差异为8.9%[95%CI，5.3%-11.7%]），同室不同床的比例更高（82.8%对70.4%；调整风险差异为12.4%[95%CI，9.3%-15.1%]），不使用柔软床上用品的比例更高（79.4%对67.6%；调整风险差异为11.8%[95%CI，8.1%-15.2%]），以及使用任何安抚奶嘴的比例更高（68.5%对59.8%；调整风险差异为8.7%[95%CI，3.9%-13.1%]）。护理质量改进干预的独立效果在所有结局中均不显著。两种干预措施之间的交互作用仅在仰卧睡眠姿势方面显著。
在健康足月儿母亲中，与对照干预措施相比，移动健康干预而非护理质量改进干预提高了对婴儿安全睡眠习惯的遵循情况。广泛实施是否可行以及是否能降低婴儿意外猝死率仍有待研究。
clinicaltrials.gov标识符：NCT01713868。
