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

NCT ID: NCT00312065

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-04-30

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.

Conditions

Impaired Thermoregulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient

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.

Group Type: EXPERIMENTAL

Application of reflective heat shield to thermistor probe

Intervention Type: DEVICE

Interventions

Application of reflective heat shield to thermistor probe

Intervention Type: DEVICE

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

• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alan de Klerk

Associate Director of Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan M de Klerk, MBChB

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

#03/10/VA03

Identifier Type: -

Identifier Source: org_study_id