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Radiant Warmer Trial

Primary Purpose

Body Temperature Changes

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GEHC IWS 4400 & Giraffe Warmer beds
GEHC IWS 4400 & Giraffe Warmer beds
GEHC IWS 4400 & Giraffe Warmer beds
GEHC IWS 4400 & Giraffe Warmer beds
GEHC IWS 4400 & Giraffe warmer beds
GEHC IWS 4400 & Giraffe Warmer beds
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Body Temperature Changes

Eligibility Criteria

32 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Radiant warmer bed sequence 1

    Radiant warmer bed sequence 2

    Radiant warmer bed sequence 3

    Radiant warmer bed sequence 4

    Radiant warmer bed sequence 5

    Radiant warmer bed sequence 6

    Arm Description

    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.

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Abdominal skin surface temperatures and axillary temperatures under 3 radiant warmer conditions as measured by skin thermistors and infrared thermography (IRT).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 10, 2009
    Last Updated
    September 10, 2015
    Sponsor
    GE Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01011855
    Brief Title
    Radiant Warmer Trial
    Official Title
    A Comparison of Thermal Responses Among Newborns to Proportional Versus Adaptive Heating Algorithms in Radiant Warmer Devices
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never developed due to a change in business priority.
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GE Healthcare

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Study was withdrawn

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Temperature Changes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiant warmer bed sequence 1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Radiant warmer bed sequence 2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Radiant warmer bed sequence 3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Radiant warmer bed sequence 4
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Radiant warmer bed sequence 5
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Radiant warmer bed sequence 6
    Arm Type
    Experimental
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe Warmer beds
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe Warmer beds
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe Warmer beds
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe Warmer beds
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe warmer beds
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GEHC IWS 4400 & Giraffe Warmer beds
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy Sturtz, MD
    Organizational Affiliation
    Christiana Care
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Radiant Warmer Trial

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