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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Impaired Thermoregulation

Intervention / Treatment
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* Device: Application of reflective heat shield to thermistor probe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>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. | Device: Application of reflective heat shield to thermistor probe<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the use of the reflective heat shield on the measured skin temperature of the baby |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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servocontrolled, radiant warmer, thermistor, heat shield