Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00312065
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Alan de Klerk, Maimonides Medical Center

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.

Condition or disease Intervention/treatment Phase
Impaired Thermoregulation Device: Application of reflective heat shield to thermistor probe Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Servocontrolled Radiant Warmers and the Role of Thermistor Probe Reflective Shields in Neonates
Study Start Date : October 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Arm Intervention/treatment
Experimental: 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.
Device: Application of reflective heat shield to thermistor probe



Primary Outcome Measures :
  1. The effect of the use of the reflective heat shield on the measured skin temperature of the baby

Secondary Outcome Measures :
  1. The effect of the use of the reflective heat shield on the measured rectal temperature of the baby
  2. The effect of the use of the reflective heat shield on the measured power output of the radiant warmer


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312065


Locations
Layout table for location information
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Alan M de Klerk, MBChB Maimonides Medical Center

Layout table for additonal information
Responsible Party: Alan de Klerk, Associate Director of Neonatology, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00312065     History of Changes
Other Study ID Numbers: #03/10/VA03
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Alan de Klerk, Maimonides Medical Center:
servocontrolled
radiant warmer
thermistor
heat shield