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Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery

2011年4月28日 更新者:Christiana Care Health Services

Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.

Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.

The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.

We plan to compare

Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.

研究概览

研究类型

介入性

注册 (实际的)

104

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Delaware
      • Newark、Delaware、美国、19713
        • Christiana Care Health Systems

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 1天 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • term newborns >/= 37 weeks gestational age
  • late preterm infants >/= 35 weeks gestational age
  • admitted to the well baby nursery following delivery
  • < 24 hours of age

Exclusion Criteria:

  • Infants < 35 weeks gestational age
  • Infants currently under a radiant warmer or who have been under a radiant warmer < 1 hour prior to temperature measurement.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:非随机化
  • 介入模型:单组作业

武器和干预

参与者组/臂
干预/治疗
其他:TAT vs. RT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.
其他名称:
  • Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)
其他:TAT vs. AT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).
Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.
其他名称:
  • Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
大体时间:All temperatures will be taken within 5 minutes of each other
All temperatures will be taken within 5 minutes of each other

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael F. Bruno, MD、Christiana Care Health Services

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年10月1日

初级完成 (实际的)

2009年8月1日

研究完成 (实际的)

2009年8月1日

研究注册日期

首次提交

2008年9月29日

首先提交符合 QC 标准的

2008年9月29日

首次发布 (估计)

2008年9月30日

研究记录更新

最后更新发布 (估计)

2011年4月29日

上次提交的符合 QC 标准的更新

2011年4月28日

最后验证

2011年4月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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