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Radiant Warmer Trial

This study has been withdrawn prior to enrollment.
(Study never developed due to a change in business priority.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011855
First Posted: November 11, 2009
Last Update Posted: September 14, 2015
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.
Information provided by (Responsible Party):
GE Healthcare
November 10, 2009
November 11, 2009
September 14, 2015
December 2009
April 2011   (Final data collection date for primary outcome measure)
Abdominal skin surface temperatures and axillary temperatures under 3 radiant warmer conditions as measured by skin thermistors and infrared thermography (IRT). [ Time Frame: There is a 4-hour baseline/washout period, followed by a 20-hour data collection cycle that will be repeated for all three-treatment conditions. Samples from the bed and telethermometer will be collected electronically every 60 seconds. ]
Same as current
Complete list of historical versions of study NCT01011855 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiant Warmer Trial
A Comparison of Thermal Responses Among Newborns to Proportional Versus Adaptive Heating Algorithms in Radiant Warmer Devices
The purpose of this study is to compare three radiant warmer beds that contain different computer heating software and different bed styles. Radiant warmers are used in many neonatal intensive care units (NICU) to provide heat to infants to help regulate an infant's temperature. It is common for babies to require care on an open bed that provides heat to the baby according to the baby's needs and at the same time allows easy access to the baby for care and necessary procedures. There are different styles of beds, each with unique computer software that can guide how a bed's heater output is automatically adjusted according to a baby's temperature needs. It is unknown which style of bed or method of heating might be best. This study seeks to evaluate infant responses to three different types of radiant warmer beds.
Study was withdrawn
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Body Temperature Changes
  • Device: GEHC IWS 4400 & Giraffe Warmer beds
    Clinical care provided first on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with a proportional heater control algorithm.
  • Device: GEHC IWS 4400 & Giraffe Warmer beds
    Clinical care provided first on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm.
  • Device: GEHC IWS 4400 & Giraffe Warmer beds
    Clinical care is first provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm.
  • Device: GEHC IWS 4400 & Giraffe Warmer beds
    Clinical care is first provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm.
  • Device: GEHC IWS 4400 & Giraffe warmer beds
    Clinical care is first provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm.
  • Device: GEHC IWS 4400 & Giraffe Warmer beds
    Clinical care is first provided on a GEHC Giraffe Warmer bed with a proportional heater control algorithm, followed by care provided on a GEHC Giraffe Warmer bed with an adaptive heater control algorithm, followed by care provided on a GEHC IWS 4400 bed with a proportional heater control algorithm.
  • Active Comparator: Radiant warmer bed sequence 1
    Clinical care provided on three different types of cleared radiant warmer beds with temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe Warmer beds
  • Active Comparator: Radiant warmer bed sequence 2
    Clinical care provided on three different types of cleared radiant warmer beds with temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe Warmer beds
  • Active Comparator: Radiant warmer bed sequence 3
    Clinical care provided on three different types of cleared radiant warmer beds with temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe Warmer beds
  • Active Comparator: Radiant warmer bed sequence 4
    Clinical care provided on three different types of cleared radiant warmer beds with temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe Warmer beds
  • Experimental: Radiant warmer bed sequence 5
    Clinical care provided on three different types of cleared radiant warmer beds with infant temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe warmer beds
  • Experimental: Radiant warmer bed sequence 6
    Clinical care provided on three different types of cleared radiant warmer beds with infant temperature measurements taken for 20 hours on each of the three radiant warmer beds.
    Intervention: Device: GEHC IWS 4400 & Giraffe Warmer beds
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any baby > 32 weeks gestation and > 1500 grams that requires initial care on a radiant warmer during confinement in the neonatal intensive care unit.

Exclusion Criteria:

  • Any baby who has a skin condition that may prevent or compromise thermistor placement and interfere with accurate temperature readings from thermistors or IR camera.
  • Any baby who is deemed too sick to tolerate movement from one radiant warmer to another by the attending physician.
  • Any baby who has a medical condition or anomaly that contraindicates axillary or abdominal temperature measurements
Sexes Eligible for Study: All
32 Weeks and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01011855
Radiant Warmer Trial
No
Not Provided
Not Provided
GE Healthcare
GE Healthcare
Not Provided
Principal Investigator: Wendy Sturtz, MD Christiana Care
GE Healthcare
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP