Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial.

IF 24.7 1区 医学 Q1 PEDIATRICS
Stephanie L Merhar, Zhuopei Hu, Lori A Devlin, Songthip T Ounpraseuth, Alan E Simon, P Brian Smith, Michele C Walsh, Jeannette Y Lee, Abhik Das, Rosemary D Higgins, Margaret M Crawford, Ward Rice, David A Paul, Jessie R Maxwell, Sucheta D Telang, Camille M Fung, Tanner Wright, Anne-Marie Reynolds, Devon Hahn, Julie Ross, Jennifer M McAllister, Moira Crowley, Sophie K Shaikh, Lori Christ, Jaime Brown, Julie Riccio, Kara Wong Ramsey, Erica F Braswell, Lauren Tucker, Karen McAlmon, Krishna Dummula, Julie Weiner, Jessica R White, Meghan P Howell, Sarah Newman, Jessica N Snowden, Leslie W Young
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引用次数: 0

Abstract

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.

吃、睡、控制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:与使用芬尼根新生儿戒断评分工具的常规护理相比,使用 "吃、睡、控制"(ESC)护理方法护理的新生儿阿片戒断综合征(NOWS)婴儿接受的药物治疗更少,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护理与常规护理对婴儿喂养方式和体重变化的影响:ESC-NOW是一项分组随机试验,对象是2020年9月至2022年3月期间在美国26家医院出生的妊娠36周或36周以后的NOWS婴儿。每家医院在随机时间从常规护理过渡到ESC(研究干预)。喂养按医院惯例进行,干预措施未作规定。出院时对喂养和体重结果进行评估:干预措施:ESC vs 常规护理:主要结果和测量指标:结果包括前瞻性确定的与喂养和体重相关的次要终点。所有分析均为意向治疗,并根据研究设计进行了调整。调整后的模型还包括母婴特征:分析包括 1305 名婴儿(702 名接受常规护理,603 名接受 ESC;平均 [SD] 胎龄为 38.6 [1.3] 周;655 名 [50.2%] 男婴和 650 名 [49.8%] 女婴)。各组的基线人口特征相似。ESC组母乳喂养婴儿的比例更高(52.7% vs 41.7%;绝对差异,11%;95% CI,1.0-20.9)。接受ESC护理的婴儿中,接受纯母乳喂养(15.1% vs 6.7%;绝对差异,8.4%;95% CI,0.9-5.8)或任何母乳喂养(38.8% vs 27.4%;绝对差异,11.4%;95% CI,0.2-23.1)以及出院时直接母乳喂养的比例更高(35.2% vs 19.5%;绝对差异,15.7%;95% CI,4.1-27.3)。虽然使用ESC护理的婴儿在出生后第3天的体重z评分较低(-1.08 vs -1.01; 绝对差异,0.07; 95% CI, 0.02-0.12),但体重减轻超过10%的婴儿比例或体重减轻的最大百分比没有差异。将药物治疗加入模型后,母乳喂养的结果均无统计学意义:在这项研究中,使用ESC护理的婴儿更有可能开始并继续母乳喂养,体重减轻的百分比没有差异。ESC改善母乳喂养的原因可能是减少了药物治疗并提供了有效的非药物护理:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT04057820。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JAMA Pediatrics
JAMA Pediatrics PEDIATRICS-
CiteScore
31.60
自引率
1.90%
发文量
357
期刊介绍: JAMA Pediatrics, the oldest continuously published pediatric journal in the US since 1911, is an international peer-reviewed publication and a part of the JAMA Network. Published weekly online and in 12 issues annually, it garners over 8.4 million article views and downloads yearly. All research articles become freely accessible online after 12 months without any author fees, and through the WHO's HINARI program, the online version is accessible to institutions in developing countries. With a focus on advancing the health of infants, children, and adolescents, JAMA Pediatrics serves as a platform for discussing crucial issues and policies in child and adolescent health care. Leveraging the latest technology, it ensures timely access to information for its readers worldwide.
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