Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Condition: Body Temperature
Study type: Interventional

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.
    


Intervention name(s): Philips InnerSense Esophageal Temperature Sensor/Feeding Tube; Standard of care feeding tube
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention