Radiant Warmer Trial

This study has been terminated.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01011855
First received: November 10, 2009
Last updated: April 25, 2011
Last verified: April 2011

November 10, 2009
April 25, 2011
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01011855 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Infant Continuous Temperatures
  • Infant Episodic Temperatures
  • 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.
 
Terminated
24
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
Both
32 Weeks and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011855
Radiant Warmer Trial
No
Lynn Lynam, GE Healthcare
GE Healthcare
Not Provided
Not Provided
GE Healthcare
April 2011

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