喂养、睡眠、安抚法或常规护理治疗新生儿阿片类药物戒断。
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
机构信息
From the Larner College of Medicine, University of Vermont, Burlington (L.W.Y.); the Departments of Biostatistics (S.T.O., Z.H., J.Y.L.) and Pediatrics (J.N.S.), University of Arkansas for Medical Sciences, Little Rock; the University of Cincinnati College of Medicine and Perinatal Institute and the Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati (S.L.M., W.R., J.M.M.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.), and the Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus (E.F.B.); the Institutional Development Awards Program of the States Pediatric Clinical Trials Network, Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville (A.E.S.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda (A.A.B., R.D.H., M.C.W.) - both in Maryland; the Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park (A.D., M.M.C.), and the Duke Clinical Research Institute, Duke University School of Medicine (R.G.G., P.B.S.), and the Department of Pediatrics, Duke University (S.K.S.), Durham - all in North Carolina; Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (B.B.P.); the Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers (R.D.H.), and the Department of Pediatrics, University of South Florida, Tampa (T.W.); St. Elizabeth Healthcare, Edgewood (W.R.), and the Department of Pediatrics, University of Louisville, Louisville (S.T., L.A.D.) - both in Kentucky; the Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, DE (D.A.P.); the University of New Mexico School of Medicine, Albuquerque (J.R.M.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (C.M.F.); the Department of Pediatrics, University at Buffalo, Buffalo (A.M.R.), and the University of Rochester School of Medicine and Dentistry, Rochester (J. Riccio) - both in New York; the Oklahoma University Health Sciences Center, Oklahoma City (D.W.H.); the Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston (J. Ross), and the Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg (J.B.) - both in South Carolina; the Section on Newborn Medicine, Pennsylvania Hospital (K.M.P.), and the Hospital of the University of Pennsylvania (L.C.), Philadelphia; the Kapiolani Medical Center for Women and Children, Honolulu (K.W.R., A.); the Department of Pediatrics, University of Mississippi Medical Center, Jackson (L.T.); Winchester Hospital, Winchester, MA (K.R.M.); the Department of Pediatrics, University of Kansas Medical Center (K.D.), and Children's Mercy Hospital (J.W.) - both in Kansas City, MO; Sanford Health, Sioux Falls, SD (J.R.W.); Tulane University School of Medicine, New Orleans (M.P.H.); and the University of Nebraska Medical Center, Omaha (S.N.).
出版信息
N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.
BACKGROUND
Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown.
METHODS
In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death.
RESULTS
A total of 1305 infants were enrolled. In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P<0.001). The incidence of adverse outcomes was similar in the two groups.
CONCLUSIONS
As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).
背景
尽管临床医生传统上一直使用 Finnegan 新生儿戒断评分工具来评估新生儿阿片类药物戒断的严重程度，但一种基于功能的新方法——“进食、睡眠、安抚”护理方法——的使用正在增加。当这种新方法在不同地点广泛应用时，是否可以安全地缩短婴儿达到可以出院的医学标准的时间尚不清楚。
方法
在这项 26 家美国医院参与的集群随机对照试验中，我们纳入了胎龄 36 周或以上且患有新生儿阿片类药物戒断综合征的婴儿。在随机指定的时间，医院从使用 Finnegan 工具的常规护理过渡到“进食、睡眠、安抚”方法。在 3 个月的过渡期间，每家医院的工作人员都接受了使用新方法的培训。主要结局是从出生到按照试验定义达到可以出院的医学标准的时间。在出生后前 3 个月评估的复合安全性结局包括院内安全性、非计划性医疗保健就诊以及非意外创伤或死亡。
结果
共纳入 1305 名婴儿。在一项意向治疗分析中，包括 837 名符合出院医学标准的婴儿，从出生到准备好出院的天数在“进食、睡眠、安抚”组为 8.2 天，在常规护理组为 14.9 天（调整后的平均差异为 6.7 天；95%置信区间 [CI]，4.7 至 8.8），比率为 0.55（95%CI，0.46 至 0.65；P<0.001）。两组的不良结局发生率相似。
结论
与常规护理相比，使用“进食、睡眠、安抚”护理方法显著减少了患有新生儿阿片类药物戒断综合征的婴儿达到可以出院的医学标准的天数，而没有增加特定的不良结局。（由美国国立卫生研究院的帮助终结成瘾长期（HEAL）倡议资助；ESC-NOW ClinicalTrials.gov 编号：NCT04057820。）
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