Clinical trial NCT00312065: Study of the Need for Temperature Probe Covers for Newborn Babies on Radiant Warmers
Official title: Servocontrolled Radiant Warmers and the Role of Thermistor Probe Reflective Shields in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Impaired Thermoregulation
Keywords: servocontrolled
radiant warmer
thermistor
heat shield
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2006-04-07
Enrollment: 11
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of the use of the reflective heat shield on the measured skin temperature of the baby
Secondary outcomes:
measure: The effect of the use of the reflective heat shield on the measured rectal temperature of the baby
measure: The effect of the use of the reflective heat shield on the measured power output of the radiant warmer
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Alan M de Klerk, MBChB
role: PRINCIPAL_INVESTIGATOR
References: