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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00312065
Enrollment
11
Registered
2006-04-07
Start date
2003-10-31
Completion date
2005-04-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Thermoregulation

Keywords

servocontrolled, radiant warmer, thermistor, heat shield

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.

Interventions

DEVICEApplication of reflective heat shield to thermistor probe

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026