Radiant Warmer Trial

Body Temperature Changes Clinical Trial

Official title:

A Comparison of Thermal Responses Among Newborns to Proportional Versus Adaptive Heating Algorithms in Radiant Warmer Devices

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01011855
• Other study ID #: Radiant Warmer Trial
• Status: Withdrawn
• Phase: N/A
• First received: November 10, 2009
• Last updated: September 10, 2015
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Study was withdrawn

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal skin surface temperatures and axillary temperatures under 3 radiant warmer conditions as measured by skin thermistors and infrared thermography (IRT).		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.	Yes