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Study never developed due to a change in business priority.
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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.
Study was withdrawn
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiant warmer bed sequence 1 | Active Comparator | 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. |
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| Radiant warmer bed sequence 2 | Active Comparator | 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. |
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| Radiant warmer bed sequence 3 | Active Comparator | 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. |
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| Radiant warmer bed sequence 4 | Active Comparator | 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. |
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| Radiant warmer bed sequence 5 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEHC IWS 4400 & Giraffe Warmer beds | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Sturtz, MD | Christiana Care | Principal Investigator |
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| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Radiant warmer bed sequence 6 | Experimental | 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. |
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| GEHC IWS 4400 & Giraffe Warmer beds | Device | 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. |
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| GEHC IWS 4400 & Giraffe Warmer beds | Device | 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. |
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| GEHC IWS 4400 & Giraffe Warmer beds | Device | 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. |
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| GEHC IWS 4400 & Giraffe warmer beds | Device | 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. |
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| GEHC IWS 4400 & Giraffe Warmer beds | Device | 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. |
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