Trial Outcomes & Findings for Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants (NCT NCT02311972)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

Admission

Results posted on

2017-06-14

Participant Flow

Of 52 enrolled infants, 20 infants were randomized. Of those not randomized, 18 were over/underweight, 8 mothers were discharged prior to delivery/lost to contact, 5 infants were not enrolled due to no page at infant delivery and 1 was not enrolled because the infant did not a require feeding tube per attending physician at delivery.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control - Standard of Care n=12 Participants Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. 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. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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, and 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. All temperatures entered into the study database.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Admission

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

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Mean Axillary Admission Temperature	36.77 Degrees Celsius Standard Deviation 0.61	36.68 Degrees Celsius Standard Deviation 0.51

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Mean Axillary Temperature at 4 Hours of Infant Life	36.93 Degrees Celsius Standard Deviation 0.27	36.74 Degrees Celsius Standard Deviation 0.42

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=12 Participants 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.	Philips InnerSense Esophageal Temperature Sensor/Feeding Tube n=8 Participants 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.
Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Admission to 24 hours of infant life.

Population: 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.

Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient.

Outcome measures

Outcome measures
Measure	Control - Standard of Care n=5 Participants 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.	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.
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. Infant 007	0.534 Pearson Correlation Coefficient	—
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. Infant 010	0.692 Pearson Correlation Coefficient	—
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. Infant 015	0.713 Pearson Correlation Coefficient	—
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. Infant 039	0.152 Pearson Correlation Coefficient	—
Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. Infant 040	0.023 Pearson Correlation Coefficient	—

OTHER_PRE_SPECIFIED outcome

Timeframe: First 24 hours of infant life.

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.

Outcome measures

Outcome data not reported

Adverse Events

Control - Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Philips InnerSense Esophageal Temperature Sensor/Feeding Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robin B. Dail

Duke University

Phone: 919-684-3786

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place