Body Temperature
Conditions
Brief summary
Very low birth weight (VLBW) infants (\<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care. The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with a digital temperature display will enable care-providers to monitor continuous body temperature and prompt them to provide warmth and prevent heat loss, thus preventing hypothermia in these infants for the first 24 hours of life. The investigator predicts infants in the intervention group will have warmer axillary temperatures upon admission to the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW infants and other low birth weight infants 1000-2000 grams will be randomized to the intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel monitor for continuous digital temperature display, immediately after birth through 24 hours of life) or the control group (standard delivery room care and stabilization care). The study staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers who care for an InnerSense study infant and wish to complete a provider satisfaction survey. These providers will be asked to provide consent prior to completing the survey and their names will be recorded on a separate study enrollment log. Infant demographic data will be compared to make sure groups are not significantly different. Temperatures from the intervention group will be compared to the control group using a student t test at each time point. Satisfaction questionnaires will be summarized and described. The InnerSense oral gastric tube with temperature monitoring is FDA approved for use and is being marketed commercially by Philips Healthcare. VLBW infants have oral gastric tubes placed as standard of care for feeding, and intermittently in the delivery room when positive pressure ventilation is necessary for respiratory stabilization. There are no additional safety risks to the intervention of this study; however, a safety/data monitoring committee will be formed and meet quarterly to monitor the trial.
Interventions
DEVICEStandard of care feeding tube
DEVICEPhilips InnerSense Esophageal Temperature Sensor/Feeding Tube
Sponsors
Philips Healthcare
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Parents of eligible infants must be enrolled prior to, or shortly after delivery as the InnerSense esophageal temperature sensor/feeding tube will be inserted post delivery resuscitation
Exclusion criteria
* Infants are excluded if parents were not consented prior to, or shortly after delivery * Infants are not eligible if they have major congenital anomalies including gastrointestinal or facial abnormalities * Infants with major cardiac anomalies are also excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Axillary Temperature at 4 Hours of Infant Life | 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. |
| Mean Axillary Admission Temperature | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life | 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. |
| Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life | 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. |
| Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Admission to 24 hours of infant life. | Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient. |
| Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life | 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. |
| Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome: Caregiver Satisfaction and Ease of Use | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control - Standard of Care 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. | 12 |
| 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, 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. | 8 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control - Standard of Care | Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 8 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 6 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 12 participants | 8 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 0 / 12 | 0 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 |
Outcome results
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
Time frame: Admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Standard of Care | Mean Axillary Admission Temperature | 36.77 Degrees Celsius | Standard Deviation 0.61 |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Mean Axillary Admission Temperature | 36.68 Degrees Celsius | Standard Deviation 0.51 |
p-value: 0.7294t-test, 2 sided
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.
Time frame: 4 Hours of Infant Life
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Standard of Care | Mean Axillary Temperature at 4 Hours of Infant Life | 36.93 Degrees Celsius | Standard Deviation 0.27 |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Mean Axillary Temperature at 4 Hours of Infant Life | 36.74 Degrees Celsius | Standard Deviation 0.42 |
p-value: 0.236t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control - Standard of Care | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Infant 007 | 0.534 Pearson Correlation Coefficient |
| Control - Standard of Care | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Infant 010 | 0.692 Pearson Correlation Coefficient |
| Control - Standard of Care | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Infant 015 | 0.713 Pearson Correlation Coefficient |
| Control - Standard of Care | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Infant 039 | 0.152 Pearson Correlation Coefficient |
| Control - Standard of Care | Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm. | Infant 040 | 0.023 Pearson Correlation Coefficient |
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: 0.3947t-test, 2 sided
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.
Time frame: 1 Hour of Infant Life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Standard of Care | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life | 1 Participants |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life | 4 Participants |
p-value: 0.1089t-test, 2 sided
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.
Time frame: 4 Hours of Infant Life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Standard of Care | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life | 1 Participants |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life | 1 Participants |
p-value: 0.05t-test, 2 sided
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.
Time frame: 8 Hours of Infant Life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Standard of Care | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life | 2 Participants |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life | 0 Participants |
p-value: 0.4947t-test, 2 sided
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.
Time frame: Admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Standard of Care | Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission | 5 Participants |
| Philips InnerSense Esophageal Temperature Sensor/Feeding Tube | Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission | 3 Participants |
p-value: 0.05t-test, 2 sided
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.
Time frame: First 24 hours of infant life.