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儿科重症监护室中营养不良儿童延迟肠外营养 1 周与 24 小时内启动的结局比较:PEPaNIC 随机临床试验的亚组分析。

Outcomes of Delaying Parenteral Nutrition for 1 Week vs Initiation Within 24 Hours Among Undernourished Children in Pediatric Intensive Care: A Subanalysis of the PEPaNIC Randomized Clinical Trial.

机构信息

Department of Pediatrics and Pediatric Surgery, Intensive Care Unit, Erasmus MC-Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.

Division of Pediatric Gastroenterology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.

出版信息

JAMA Netw Open. 2018 Sep 7;1(5):e182668. doi: 10.1001/jamanetworkopen.2018.2668.

DOI:10.1001/jamanetworkopen.2018.2668
PMID:30646158
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6324499/
Abstract

IMPORTANCE

Undernourishment has been associated with poor outcomes of critical illness in children. The effects of withholding parenteral nutrition (PN) for 1 week in undernourished critically ill children are unknown.

OBJECTIVE

To assess the outcome effects of withholding PN for 1 week in undernourished critically ill children.

DESIGN, SETTING, AND PARTICIPANTS: This is a subanalysis of the randomized clinical trial Pediatric Early vs Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC; N = 1440), which focused on the subgroup of pediatric intensive care unit (PICU) patients identified as undernourished on admission. Children included in the PEPaNIC trial were enrolled between June 18, 2012, and July 27, 2015. Undernourishment was defined as weight-for-age z score less than -2 in children younger than 1 year, and body mass index-for-age z score less than -2 in children 1 year or older. Data analysis was conducted from August 3, 2017, to July 6, 2018.

INTERVENTIONS

Patients were randomized to initiation of supplemental PN within 24 hours (early PN) or after 1 week (late PN) when enteral nutrition was insufficient.

MAIN OUTCOMES AND MEASURES

Primary end points were risk of new infections acquired in the PICU and time to live PICU discharge, assessed via multivariable logistic regression and Cox proportional hazard analyses, adjusted for risk factors.

RESULTS

A total of 289 of 1440 children (20.1%), term newborn to age 17 years, were identified as undernourished, of whom 150 of 717 patients (20.9%) were in the late PN group and 139 of 723 patients (19.2%) were in the early PN group. On admission, characteristics were similar among the treatment groups. Mean (SD) weight z scores were -3.33 (1.18) in the late PN group and -3.21 (1.09) in the early PN group. Compared with well-nourished PICU patients, undernourishment on admission was associated with lower likelihood of an earlier live PICU discharge (adjusted hazard ratio, 0.86; 95% CI, 0.75-0.99; P = .03). Among undernourished PICU patients, late PN reduced the risk of new infections by 11.0% (adjusted odds ratio, 0.39; 95% CI, 0.19-0.78; P = .01), and shortened the duration of PICU stay by a median of 2 days (earlier live PICU discharge: adjusted hazard ratio, 1.37; 95% CI, 1.06-1.75; P = .01). The safety outcomes mortality, incidence of hypoglycemia during the first week, and incidence of weight deterioration during PICU stay were similar between the treatment groups.

CONCLUSIONS AND RELEVANCE

In undernourished critically ill children, withholding PN for 1 week was clinically superior to early PN.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01536275.

摘要

重要性

营养不良与儿童危重症的不良结局有关。在营养不良的危重症儿童中,暂停肠外营养(PN)1 周的效果尚不清楚。

目的

评估在营养不良的危重症儿童中暂停 PN 1 周的结局影响。

设计、地点和参与者:这是儿科早期与晚期重症监护室肠外营养(PEPaNIC;N=1440)的随机临床试验的亚组分析,该研究重点关注入院时被确定为营养不良的儿科重症监护病房(PICU)患者亚组。PEPaNIC 试验纳入的儿童于 2012 年 6 月 18 日至 2015 年 7 月 27 日期间入组。营养不良定义为年龄小于 1 岁的儿童体重与年龄的 Z 评分小于-2,1 岁及以上的儿童体质量指数与年龄的 Z 评分小于-2。数据分析于 2017 年 8 月 3 日至 2018 年 7 月 6 日进行。

干预措施

患者随机分配在 24 小时内(早期 PN)或肠内营养不足时 1 周后(晚期 PN)开始补充 PN。

主要终点

通过多变量逻辑回归和 Cox 比例风险分析评估重症监护病房新发感染风险和住重症监护病房至出院的时间,调整了危险因素。

结果

在 1440 名儿童中,共有 289 名(20.1%),包括足月新生儿至 17 岁,被确定为营养不良,其中晚期 PN 组有 717 名患者中的 150 名(20.9%),早期 PN 组有 723 名患者中的 139 名(19.2%)。入院时,两组患者的特征相似。晚期 PN 组的平均(SD)体重 Z 评分为-3.33(1.18),早期 PN 组为-3.21(1.09)。与营养良好的 PICU 患者相比,入院时的营养不良与更早的 PICU 存活出院的可能性较低相关(调整后的危险比,0.86;95%CI,0.75-0.99;P=0.03)。在营养不良的 PICU 患者中,晚期 PN 降低了 11.0%的新发感染风险(调整后的优势比,0.39;95%CI,0.19-0.78;P=0.01),并缩短了 PICU 住院时间中位数 2 天(更早的 PICU 存活出院:调整后的危险比,1.37;95%CI,1.06-1.75;P=0.01)。两组治疗组的死亡率、第 1 周低血糖发生率和 PICU 期间体重恶化发生率等安全性结局相似。

结论和相关性

在营养不良的危重症儿童中,暂停 PN 1 周的效果优于早期 PN。

试验注册

ClinicalTrials.gov 标识符:NCT01536275。

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