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临床试验/NCT00312065
NCT00312065已完成1 期

Servocontrolled Radiant Warmers and the Role of Thermistor Probe Reflective Shields in Neonates

Maimonides Medical Center2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
11
试验地点
2
主要终点
The effect of the use of the reflective heat shield on the measured skin temperature of the baby

研究概览

简要总结

The purpose of this study is to examine the need for reflective heat shield covers over the temperature probes applied to the skin of newborn babies who are being nursed under a radiant warmer.

详细描述

Servocontrolled radiant warmers are widely used for infants' temperature maintenance. Covering the attached skin temperature (or thermistor) probe with a reflective shield may prevent inadvertent warming of the probe by the radiant heat source. However the shield itself might cause falsely elevated or lowered measured skin temperatures, and the use of such shields, while widespread, is not universal nor standard of care. This study aims to document the effects of a reflective shield on the measured skin temperatures of neonates nursed under radiant warmers.

Stable newborn infants in the Maimonides NICU who are being nursed under a radiant warmer will be studied. As part of routine care, the thermistor probe will be applied and the desired servocontrolled skin temperature set. Once stabilized, a trimmed reflective shield to cover only the probe itself will be placed over the thermistor probe. Changes in measured skin temperature and warmer power output will be recorded non-invasively, as well as the time taken to reestablish baseline status. A full-sized reflective shield will then be placed over the thermistor probe and the same observations recorded, then repeated 15 minutes later. At the time of a subsequent routine change in thermistor position, the same procedure will be followed, but omitting the intermediate step of using the smaller trimmed shield. Continuous core temperatures will be monitored via a short rectal probe during the study periods.

The effect of the use of the different size temperature probes will be examined by analyzing the effect on measured skin temperature.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 1 Week(Child)
性别
All
接受健康志愿者

入选标准

  • Stable newborn infants greater than 1000g birth weight
  • On room air or on CPAP in 21% oxygen
  • Being nursed under radiant warmer

排除标准

  • Major congenital anomalies
  • Significant dermatological pathology or abnormalities
  • Documented or suspected sepsis

结局指标

主要结局

The effect of the use of the reflective heat shield on the measured skin temperature of the baby

次要结局

  • The effect of the use of the reflective heat shield on the measured power output of the radiant warmer
  • The effect of the use of the reflective heat shield on the measured rectal temperature of the baby

研究者

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

Alan de Klerk

Associate Director of Neonatology

Maimonides Medical Center

研究点 (2)

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