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Radiant Warmer Trial

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General Electric (GE)

Status

Withdrawn

Conditions

Body Temperature Changes

Treatments

Device: GEHC IWS 4400 & Giraffe warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds

Study type

Interventional

Funder types

Industry

Identifiers

NCT01011855
Radiant Warmer Trial

Details and patient eligibility

About

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.

Full description

Study was withdrawn

Sex

All

Ages

32+ weeks old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 6 patient groups

Radiant warmer bed sequence 1
Active Comparator group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Radiant warmer bed sequence 2
Active Comparator group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Radiant warmer bed sequence 3
Active Comparator group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Radiant warmer bed sequence 4
Active Comparator group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Radiant warmer bed sequence 5
Experimental group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe warmer beds
Radiant warmer bed sequence 6
Experimental group
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.
Treatment:
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds
Device: GEHC IWS 4400 & Giraffe Warmer beds

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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