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

This study has been completed.
Sponsor:
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00312065
First received: April 5, 2006
Last updated: September 30, 2010
Last verified: October 2005

April 5, 2006
September 30, 2010
October 2003
April 2005   (final data collection date for primary outcome measure)
The effect of the use of the reflective heat shield on the measured skin temperature of the baby
Same as current
Complete list of historical versions of study NCT00312065 on ClinicalTrials.gov Archive Site
  • The effect of the use of the reflective heat shield on the measured rectal temperature of the baby
  • The effect of the use of the reflective heat shield on the measured power output of the radiant warmer
Same as current
Not Provided
Not Provided
 
Study of the Need for Temperature Probe Covers for Newborn Babies on Radiant Warmers
Servocontrolled Radiant Warmers and the Role of Thermistor Probe Reflective Shields in Neonates

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thermoregulation
Device: Application of reflective heat shield to thermistor probe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
up to 1 Week
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00312065
#03/10/VA03
No
Not Provided
Maimonides Medical Center
Not Provided
Principal Investigator: Alan M de Klerk, MBChB Maimonides Medical Center
Maimonides Medical Center
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP