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Completed

NCT Number: NCT00312065

Study of the Need for Temperature Probe Covers for Newborn Babies on Radiant Warmers

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.

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Key information

Age range

Up to 1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Application of reflective heat shield to thermistor probe

Device

Primary outcomes

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

Secondary outcomes

  1. The effect of the use of the reflective heat shield on the measured rectal temperature of the baby

  2. The effect of the use of the reflective heat shield on the measured power output of the radiant warmer

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 7, 2006
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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