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

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 1000-1700 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.