A Quantitative, Risk-Based Approach to the Management of Neonatal Early-Onset Sepsis
A Quantitative, Risk-Based Approach to the Management of Neonatal Early-Onset Sepsis
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DOI：
10.1001/jamapediatrics.2016.4678
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发表时间：
2017-04-01
期刊：
影响因子：
26.1
通讯作者：
Escobar, Gabriel J.
中科院分区：
文献类型：
--
作者：
Kuzniewicz, Michael W.;Puopolo, Karen M.;Escobar, Gabriel J.
重要性：目前处理新生儿早发性败血症（EOS）的算法导致对大量未感染婴儿进行医疗干预。基于出生时的客观数据和新生儿的临床状况，我们开发了多变量预测模型来估计晚期早产儿和足月婴儿发生EOS的风险。目的研究新生儿EOS风险预测模型对脓毒症评估和抗生素使用的影响，并评估其在大型综合医疗系统中的安全性。设计、环境和参与者研究队列包括2010年1月1日至2015年12月31日期间在Kaiser Permanente北加州医院出生的妊娠35周或更晚的204,485名婴儿。本研究比较了三个时期EOS管理基于(1)国家推荐指南（基线期[2010年1月1日至2012年11月31日]），(2)出生时脓毒症风险的多变量估计（学习期[2012年12月1日至2014年6月30日]），以及(3)多变量风险估计结合婴儿出生后24小时的临床状况（EOS计算器期[2014年7月1日至2015年12月31日]）。主要结局和措施主要结局是在最初24小时内使用抗生素。次要结局包括血培养使用情况、24 - 72小时抗生素使用情况、临床结局和再入院情况。结果：研究队列包括204,485名妊娠35周或更晚出生的婴儿：基线期95 343名（平均[SD]年龄，39.4[1.3]周；46 651名男性[51.0%]；37 007名白人，非西班牙裔[38.8%]），学习期52 881名（平均[SD]年龄，39.3[1.3]周；27 067名男性[51.2%]；20 175名白人，非西班牙裔[38.2%]），EOS计算期56 261名（平均[SD]年龄，39.4[1.3]周；28 575名男性[50.8%]；20 484名白人，非西班牙裔[36.4%]）。在基线期与EOS计算器期的比较中，血培养使用率从14.5%下降到4.9%（调整差，-7.7%;95% CI, -13.1%至-2.4%）。前24小时的经验性抗生素给药率从5.0%降至2.6%（调整后差异为-1.8；95% CI为-2.4%至-1.3%）。出生后24至72小时内抗生素使用没有增加；使用率从0.5%下降到0.4%（调整差，0.0%;95% CI, -0.1%至0.2%）。在3个时期，培养证实的EOS发病率相似（基线期0.03%，学习期0.03%，EOS计算器期0.02%）。EOS再入院（出生后7天内）在所有时期都很少见（基线期为每10万例5.2例，学习期为每10万例1.9例，EOS计算器期为每10万例5.3例），且无统计学差异（P = 0.70）。引入EOS计算器后，不良临床结果的发生率，包括需要使用收缩性药物、机械通气、脑膜炎和死亡，没有变化。基于多变量风险预测模型得出的个体婴儿EOS风险估计的临床护理算法降低了接受实验室检测和接受无明显不良反应的经验性抗生素治疗的新生儿比例。
IMPORTANCE Current algorithms for management of neonatal early-onset sepsis (EOS) result in medical intervention for large numbers of uninfected infants. We developed multivariable prediction models for estimating the risk of EOS among late preterm and term infants based on objective data available at birth and the newborn's clinical status.OBJECTIVES To examine the effect of neonatal EOS risk prediction models on sepsis evaluations and antibiotic use and assess their safety in a large integrated health care system.DESIGN, SETTING, AND PARTICIPANTS The study cohort includes 204 485 infants born at 35 weeks' gestation or later at a Kaiser Permanente Northern California hospital from January 1, 2010, through December 31, 2015. The study compared 3 periods when EOS management was based on (1) national recommended guidelines (baseline period [January 1, 2010, through November 31, 2012]), (2) multivariable estimates of sepsis risk at birth (learning period [December 1, 2012, through June 30, 2014]), and (3) the multivariable risk estimate combined with the infant's clinical condition in the first 24 hours after birth (EOS calculator period [July 1, 2014, through December 31, 2015]).MAIN OUTCOMES AND MEASURES The primary outcome was antibiotic administration in the first 24 hours. Secondary outcomes included blood culture use, antibiotic administration between 24 and 72 hours, clinical outcomes, and readmissions for EOS.RESULTS The study cohort included 204 485 infants born at 35 weeks' gestation or later: 95 343 in the baseline period (mean [SD] age, 39.4 [1.3] weeks; 46 651 male [51.0%]; 37 007 white, non-Hispanic [38.8%]), 52 881 in the learning period (mean [SD] age, 39.3 [1.3] weeks; 27 067 male [51.2%]; 20 175 white, non-Hispanic [38.2%]), and 56 261 in the EOS calculator period (mean [SD] age, 39.4 [1.3] weeks; 28 575 male [50.8%]; 20 484 white, non-Hispanic [36.4%]). In a comparison of the baseline period with the EOS calculator period, blood culture use decreased from 14.5% to 4.9%(adjusted difference, -7.7%; 95% CI, -13.1% to -2.4%). Empirical antibiotic administration in the first 24 hours decreased from 5.0% to 2.6% (adjusted difference, -1.8; 95% CI, -2.4% to -1.3%). No increase in antibiotic use occurred between 24 and 72 hours after birth; use decreased from 0.5% to 0.4%(adjusted difference, 0.0%; 95% CI, -0.1% to 0.2%). The incidence of culture-confirmed EOS was similar during the 3 periods (0.03% in the baseline period, 0.03% in the learning period, and 0.02% in the EOS calculator period). Readmissions for EOS (within 7 days of birth) were rare in all periods (5.2 per 100 000 births in the baseline period, 1.9 per 100 000 births in the learning period, and 5.3 per 100 000 births in the EOS calculator period) and did not differ statistically (P =.70). Incidence of adverse clinical outcomes, including need for inotropes, mechanical ventilation, meningitis, and death, was unchanged after introduction of the EOS calculator.CONCLUSIONS AND RELEVANCE Clinical care algorithms based on individual infant estimates of EOS risk derived from a multivariable risk prediction model reduced the proportion of newborns undergoing laboratory testing and receiving empirical antibiotic treatment without apparent adverse effects.