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临床试验/NCT02354521
NCT02354521已完成不适用

NUTRITION SUPPORT DURING PEDIATRIC CRITICAL ILLNESS - 2ND MULTICENTER, INTERNATIONAL COHORT STUDY OF BARRIERS AND OUTCOMES

Boston Children's Hospital0 个研究点目标入组 1,200 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,200
主要终点
60-day mortality

研究概览

简要总结

An observational, point-prevalence cohort study of nutrition therapies in critically ill children in PICUs across the world. Baseline information will be collected including PICU and hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score, weight, height) of critically ill children requiring mechanical ventilation in the PICU. Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed and received, interruptions, etc., will be collected on a daily basis from PICU admission onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days after admission to the PICU. The main objective of the study is to examine the association between energy and protein intake adequacy (in relation to the prescribed goals for these nutrients) and 60-day mortality in mechanically ventilated children.

详细描述

Nutrition Support can prevent complications associated with malnutrition and when used appropriately has a positive influence on clinically important outcomes, such as length of stay, morbidity and mortality. Making decisions regarding the most effective and safe nutrition support can be challenging, and consequently considerable variation exists in nutrition support practices in PICUs.

This is a multicenter prospective cohort study of nutritional practices in mechanically ventilated children from a representative sample of medium to large (at least 8 ICU beds) PICUs in North America and participating centers across other countries. The investigators will invite centers in all 9 US Census regions, at least 3 Canadian Provinces and PICUs with 8 or more beds from across the world. Participating sites will be recruited through the PALISI network (of more than 66 PICUs), by disseminating study information through national nutrition (e.g. ASPEN) and critical care societies (e.g. (SCCM), and e-mailing individual healthcare providers.

Patient selection criteria: All children (ages 1month to 18 years) admitted to the PICU, who require mechanical ventilatory support with anticipated duration of stay longer than 48 hours will be eligible for data collection. Data collection for each eligible patient will be continued for a total of 10 days or until discharge from the PICU (if earlier) until a minimum of 15 patients (maximum 40 patients) are accrued per site. The investigators anticipate recruitment of 500 patients.

The trained dietitians (or a designated research nurse) at participating centers will use a validated web-based remote data capture tool to record details of nutritional intake. An instruction package describing data collection methods in detail will be provided. Following a training period, beginning on the 'going live' date, the dietitian or designated coordinator at participating centers will simultaneously enter relevant data online using a secure website.

Nutritional variables including the energy and protein goals prescribed by the local nutrition team, actual daily macronutrient delivery achieved, route of delivery, frequency and duration of feeding interruptions, and use of adjunctive drugs, will be recorded. Prescribed protein goals for each subject will be compared to the recommended daily protein in the 2005 DRI and the 2009 A.S.P.E.N. age-based guidelines. The end point for nutritional data collection is 10 days or discharge from the PICU, whichever was sooner. The energy and protein intake adequacy will be calculated as the percentage of the prescribed goal that was actually delivered and an average adequacy over the PICU stay up to 10 days was derived.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1 month to 18 yrs
  • PICU anticipated stay longer than 48 hours, on mechanical ventilatory support

排除标准

  • Patients who were not ventilated within the first 48 hours of admission to PICU
  • On compassionate care toward end-of-life
  • Those enrolled in any other nutritional intervention trial will be excluded

结局指标

主要结局

60-day mortality

时间窗: 60 days

次要结局

  • Acquired infections(PICU stay)
  • Ventilator free days(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilesh M. Mehta

Associate Professor of Anesthesia, Critical Care

Boston Children's Hospital

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