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临床试验/NCT04271995
NCT04271995已完成不适用

A Diagnostic Accuracy Study Evaluating Point of Care Gastric Lipase Enhanced pH Test Strip to Confirm Correct Nasogastric Tube Position in Newborn Infant

Imperial College London1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2020年3月2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
233
试验地点
1
主要终点
Sensitivity of standard and ingenza pH strips

研究概览

简要总结

The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. The bedside nurse inserts the tube and then aspirate some of the fluid from the stomach. As the stomach normally produce acid, these aspirate is then tested on a colour coded paper strip to check if the fluid is acidic. However, on many occasions this test is not very clear. This could be due to misplacement of the tube or the stomach in a newborn not being able to produce enough acid. This then leads to re-siting of another tube and following the same procedure. Sometimes the clinical team may like to do an X Ray to check the position of the tube resulting in unnecessary exposure to radiation. The study will use a special chemical added to the currently existing paper test strip which the investigators believe will enhance the capability of detecting the correct position of the NG tube. This idea has been tested in adults and found to have increased the sensitivity of the test strip significantly. Based on the adult study the study will require to test 233 babies to see if this increases the sensitivity of correct NG tube placement. Parents of all babies who requires an NG tube for milk feeds will be approached and after appropriate consent could be recruited to the study. Babies who are clinically very unstable, moribund and those with diagnosis of bowel obstruction will be excluded from the study.

详细描述

STUDY OBJECTIVES

Primary Objective:

• To determine the sensitivity of the chemical (tributyrin) impregnated pH test strip in comparison to the routine pH test strip to increase the sensitivity of detection of correct positioning of the nasogastric tube

Secondary objectives:

  • To measure the number of nasogastric tube re-insertion attempts that could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
  • To determine the number of chest radiographs which could be avoided if the tributyrin impregnated pH test strip was used instead of the standard pH test strip
  • To carry out human factors assessment of perceived usability, trust and acceptance of the lipase-based pH test strip

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 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management

排除标准

  • Clinically unstable, critically ill infants
  • Infants undergoing palliative care
  • Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction

结局指标

主要结局

Sensitivity of standard and ingenza pH strips

时间窗: 6 months

Where test sensitivity is defined as the proportion of pH readings that are equal to or below (\<=) a certain cut-off when aspirates are obtained from tubes placed inside the stomach. Stomach placements are confirmed either by chest x-rays, or in its absence, by clinical observations).

次要结局

  • Specificity of standard and ingenza pH strips(6 months)
  • Time to confirm tube placement(6 months)
  • Number of chest x rays performed(6 months)
  • Number of nasogastric tube attempts to get the correct pH(6 months)
  • pH readings obtained by standard and ingenza strips under all cut-offs(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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