| Primary | Mean Axillary Admission Temperature | Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference | | Posted | | Mean | Standard Deviation | Degrees Celsius | | Admission | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00036.77± 0.61
- OG00136.68± 0.51
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.7294 | | | | | | | | | | | | | | Superiority | Mean axillary admission temperature | |
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| Primary | Mean Axillary Temperature at 4 Hours of Infant Life | The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life. | | Posted | | Mean | Standard Deviation | Degrees Celsius | | 4 Hours of Infant Life | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Secondary | Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission | Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared on admission to determine the percentage of hypothermia in both groups. | | Posted | | Count of Participants | | Participants | | Admission | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Secondary | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life | Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 1 hour to determine the percentage of hypothermia in both groups. | | Posted | | Count of Participants | | Participants | | 1 Hour of Infant Life | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Secondary | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life | Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 4 hours to determine the percentage of hypothermia in both groups. | | Posted | | Count of Participants | | Participants | | 4 Hours of Infant Life | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Secondary | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life | Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 8 hours to determine the percentage of hypothermia in both groups. | | Posted | | Count of Participants | | Participants | | 8 Hours of Infant Life | | | | ID | Title | Description |
|---|
| OG000 | Control - Standard of Care | Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. | | OG001 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Secondary | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient. | Intervention Group Only: Two infants with the InnerSense did not have skin temperatures dowloaded from the data logger due to data logger malfunction and one infant had a Squirrel monitor attached to the InnerSense tube that did not read or log temperatures. Therefore only data from 5 infants was available to analyze. | Posted | | Number | | Pearson Correlation Coefficient | | Admission to 24 hours of infant life. | | | | ID | Title | Description |
|---|
| OG000 | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. |
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| Other Pre-specified | Exploratory Outcome: Caregiver Satisfaction and Ease of Use | Describe the caregiver satisfaction and ease of use for the InnerSense by using a provider questionnaire. Caregivers will rate the InnerSense feeding tube with traditional feeding tubes used in the Intensive Care Nursery. | | Not Posted | | | | | | First 24 hours of infant life. | | Participants | | | | |