Radiant Warmer Trial

Not Applicable

Withdrawn

• Conditions: Body Temperature Changes
• Interventions: Device: GEHC IWS 4400 & Giraffe warmer beds

• Registration Number: NCT01011855
• Lead Sponsor: GE Healthcare

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Study was withdrawn

Study Timeline

• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Study Start: 2009-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Radiant warmer bed sequence 1	GEHC IWS 4400 & Giraffe 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.
Radiant warmer bed sequence 4	GEHC IWS 4400 & Giraffe 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.
Radiant warmer bed sequence 6	GEHC IWS 4400 & Giraffe 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.
Radiant warmer bed sequence 5	GEHC IWS 4400 & Giraffe 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.
Radiant warmer bed sequence 2	GEHC IWS 4400 & Giraffe 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.
Radiant warmer bed sequence 3	GEHC IWS 4400 & Giraffe 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.

Primary Outcome Measures

Name	Time	Method
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.