Clinical trial NCT02311972: Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Official title: Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2014-12-09
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Axillary Admission Temperature
timeFrame: Admission
measure: Mean Axillary Temperature at 4 Hours of Infant Life
timeFrame: 4 Hours of Infant Life
Secondary outcomes:
measure: Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission
timeFrame: Admission
measure: Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life
timeFrame: 1 Hour of Infant Life
measure: Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life
timeFrame: 4 Hours of Infant Life
measure: Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life
timeFrame: 8 Hours of Infant Life
measure: Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.
timeFrame: Admission to 24 hours of infant life.
Other outcomes:
measure: Exploratory Outcome: Caregiver Satisfaction and Ease of Use
timeFrame: First 24 hours of infant life.
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing & School of Medicine, Department of Pediatrics
name: Robin B Dail (Knobel), PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
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