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临床试验/NCT04127773
NCT04127773已完成不适用

Correct Gastric Tube Placement in Very Low Birth Weight Neonates: Comparison of NEX and NEMU Methods

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2015年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Gastric tube position

研究概览

简要总结

Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.

Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.

Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.

详细描述

Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.

Hence, primary aim of this study is:

To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.

Secondary aim is:

  • To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants

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
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
  • Need for both umbilical catheter and gastric tube positioning at birth

排除标准

  • Birth Weight >1500 grams
  • Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
  • Critically unstable preterm infants will be excluded according to nurse or physician evaluation

结局指标

主要结局

Gastric tube position

时间窗: within 24 hours

Control on X-ray chest of the gastric tube placement by NEX and NEMU methods

次要结局

未报告次要终点

研究者

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

Chiara Baracetti

Registered Nurse

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (1)

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