Radiant Warmer 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.

Conditions

• Body Temperature Changes

Interventions

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.

Sponsors & Collaborators

• GE Healthcare

  lead INDUSTRY

Principal Investigators

• Wendy Sturtz, MD · Christiana Care

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2011-04-30

Completion

2011-04-30