Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312065
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2006-04-05
Brief Title:
Study of the Need for Temperature Probe Covers for Newborn Babies on Radiant Warmers
Sponsor:
Maimonides Medical Center
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Servocontrolled Radiant Warmers and the Role of Thermistor Probe Reflective Shields in Neonates
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None