Importance Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown. Objective To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care. Design, Setting, and Participants ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks' gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge. Intervention ESC vs usual care. Main Outcomes and Measures Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models. Results The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (-1.08 vs -1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant. Conclusions and Relevance In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care. Trial Registration ClinicalTrials.gov Identifier: NCT04057820.

中文翻译：

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Eat， Sleep， Console 试验中的婴儿喂养和体重轨迹：随机临床试验的二次分析。


重要性 与使用 Finnegan 新生儿戒断评分工具的常规护理相比，采用 Eat， Sleep， Console （ESC） 护理方法治疗的新生儿阿片类药物戒断综合征 （NOWS） 婴儿接受的药物治疗较少，住院时间更短，但这些方法对喂养和体重的影响尚不清楚。目的 评估 ESC 与常规护理婴儿的喂养方式和体重轨迹。设计、设置和参与者ESC-NOW 是一项整群随机试验，针对 2020 年 9 月至 2022 年 3 月在 26 家美国医院出生的妊娠 36 周或更晚出生的 NOWS 婴儿。每个站点在随机时间从常规护理过渡到 ESC （研究干预）。喂养是按现场实践进行的，干预未指定。出院时评估喂养和体重结局。干预 ESC 与常规护理。主要结局和措施 结局包括前瞻性确定的与喂养和体重相关的次要终点。z 分数用于生长，以说明测量时校正的胎龄。所有分析都是意向性治疗，并根据研究设计进行了调整。调整后的模型包括母体/婴儿特征。结果 分析包括 1305 名婴儿 （常规护理 702 名，ESC 603 名;平均 [SD] 胎龄，38.6 [1.3] 周;655 名 [50.2%] 男性和 650 名 [49.8%] 女性）。各组之间的基线人口统计学特征相似。ESC 组母乳喂养婴儿的比例较高 （52.7% vs 41.7%;绝对差异，11%;95% CI，1.0-20.9）。接受 ESC 护理的婴儿接受纯母乳喂养 （15.1% 对 6.7%;绝对差异 8.4%;95% CI，0.9-5.8） 或任何母乳 （38.8% 对 27.4%;绝对差异，11.4%;95% CI，0.2-23.1），出院时直接母乳喂养（35.2% vs 19.5%;绝对差异，15.7%;95% CI，4.1-27.3）。体重减轻大于 10% 或最大体重减轻百分比的婴儿比例没有差异，尽管用 ESC 护理的婴儿在出生后体重 z 评分较低 3 （-1.08 vs -1.01;绝对差异，0.07;95% CI，0.02-0.12）。当药物治疗加入模型时，母乳喂养结局无统计学意义。结论和相关性 在这项研究中，接受 ESC 护理的婴儿更有可能开始并继续母乳喂养，并且在体重减轻百分比方面没有差异。ESC 母乳喂养的改善可能是由于减少药物治疗和提供有效的非药物治疗。Trial Registration ClinicalTrials.gov 标识符： NCT04057820.