Study Stopped
Study never developed due to a change in business priority.
Radiant Warmer Trial
A Comparison of Thermal Responses Among Newborns to Proportional Versus Adaptive Heating Algorithms in Radiant Warmer Devices
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedSeptember 14, 2015
September 1, 2015
1.3 years
November 10, 2009
September 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (6)
Radiant warmer bed sequence 1
ACTIVE COMPARATORClinical 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 2
ACTIVE COMPARATORClinical 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
ACTIVE COMPARATORClinical 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
ACTIVE COMPARATORClinical 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 5
EXPERIMENTALClinical 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 6
EXPERIMENTALClinical 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Any baby \> 32 weeks gestation and \> 1500 grams that requires initial care on a radiant warmer during confinement in the neonatal intensive care unit.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Sturtz, MD
Christiana Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
December 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 14, 2015
Record last verified: 2015-09