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首页> 外文期刊>Trials >Impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients (PEPaNIC trial): study protocol for a randomized controlled trial
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Impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients (PEPaNIC trial): study protocol for a randomized controlled trial

机译：保留早期肠外营养对小儿重症患者肠内营养的影响（PEPaNIC试验）：一项随机对照试验的研究方案

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Background The state-of-the-art nutrition used for critically ill children is based essentially on expert opinion and extrapolations from adult studies or on studies in non-critically ill children. In critically ill adults, withholding parenteral nutrition (PN) during the first week in ICU improved outcome, as compared with early supplementation of insufficient enteral nutrition (EN) with PN. We hypothesized that withholding PN in children early during critical illness reduces the incidence of new infections and accelerates recovery. Methods/Design The Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study is an investigator-initiated, international, multicenter, randomized controlled trial (RCT) in three tertiary referral pediatric intensive care units (PICUs) in three countries on two continents. This study compares early versus late initiation of PN when EN fails to reach preset caloric targets in critically ill children. In the early-PN (control, standard of care) group, PN comprising glucose, lipids and amino acids is administered within the first days to reach the caloric target. In the late-PN (intervention) group, PN completing EN is only initiated beyond PICU-day 7, when EN fails. For both study groups, an early EN protocol is applied and micronutrients are administered intravenously. The primary assessor-blinded outcome measures are the incidence of new infections during PICU-stay and the duration of intensive care dependency. The sample size (n?=?1,440, 720 per arm) was determined in order to detect a 5% absolute reduction in PICU infections, with at least 80% 1-tailed power (70% 2-tailed) and an alpha error rate of 5%. Based on the actual incidence of new PICU infections in the control group, the required sample size was confirmed at the time of an a priori- planned interim-analysis focusing on the incidence of new infections in the control group only. Discussion Clinical evidence in favor of early administration of PN in critically ill children is currently lacking, despite potential benefit but also known side effects. This large international RCT will help physicians to gain more insight in the clinical effects of omitting PN during the first week of critical illness in children. Trial registration ClinicalTrials.gov: NCT01536275 on 16 February 2012.
机译：背景技术用于重症儿童的最新营养基本上基于成人研究或非重症儿童研究的专家意见和推断。在重症成人中，与早期补充肠内营养不足（EN）相比，重症监护病房（ICU）在第一周不接受肠外营养（PN）可以改善结局。我们假设在危重疾病早期在儿童中禁用PN可以减少新感染的发生并加速康复。方法/设计儿科重症监护病房早期和晚期肠外营养研究（PEPaNIC）是一项由研究人员发起的国际多中心随机对照试验（RCT），在三个国家的三个三级转诊儿科重症监护病房（PICU）上进行，两个大洲。这项研究比较了在危重症儿童中EN未能达到预设的热量目标时，PN的早期和晚期启动。在早期PN（对照组，护理标准）组中，在头几天内施用包含葡萄糖，脂质和氨基酸的PN，以达到热量目标。在晚期PN（干预）组中，只有EN失败后，才在PICU第7天之后启动PN完成EN。对于两个研究组，均采用早期的EN方案，并通过静脉内施用微量营养素。评估者的主要盲目结局指标是住院期间重症监护病房中新感染的发生率以及重症监护依赖的持续时间。确定样本量（n？=？1,440，每臂720个），以检测PICU感染的绝对减少5％，并具有至少80％的1尾功率（70％的2尾）和alpha错误率5％。根据对照组中新PICU感染的实际发生率，在事先计划的中期分析时（仅关注对照组中新感染的发生率）确定了所需的样本量。讨论尽管有潜在的好处，但也有已知的副作用，目前尚缺乏支持重症患儿早期应用PN的临床证据。这项大型的国际RCT将帮助医生在儿童重症疾病的第一周内，省去PN的临床效果，从而获得更多的见识。试用注册ClinicalTrials.gov：2012年2月16日的NCT01536275。

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