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 1000-2000 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.

Study Overview

• Status: Completed
• Conditions: Body Temperature
• Intervention / Treatment: Device: Standard of care feeding tube; Device: Philips InnerSense Esophageal Temperature Sensor/Feeding Tube

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Standard of care feeding tube
Active Comparator: 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.	Device: Philips InnerSense Esophageal Temperature Sensor/Feeding Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Admission
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.	4 Hours of Infant Life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Admission
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.	1 Hour of Infant Life
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.	4 Hours of Infant Life
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.	8 Hours of Infant Life
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.	Admission to 24 hours of infant life.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 24 hours of infant life.

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Robin B Dail (Knobel), PhD, RN, FAAN, Duke University School of Nursing & School of Medicine, Department of Pediatrics

Publications and helpful links

General Publications

• Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
• Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.
• Bhatt DR, White R, Martin G, Van Marter LJ, Finer N, Goldsmith JP, Ramos C, Kukreja S, Ramanathan R. Transitional hypothermia in preterm newborns. J Perinatol. 2007 Dec;27 Suppl 2:S45-7. doi: 10.1038/sj.jp.7211842.
• Basu S, Rathore P, Bhatia BD. Predictors of mortality in very low birth weight neonates in India. Singapore Med J. 2008 Jul;49(7):556-60.
• Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. doi: 10.1038/sj.jp.7211289.
• Almeida PG, Chandley J, Davis J, Harrigan RC. Use of the heated gel mattress and its impact on admission temperature of very low birth-weight infants. Adv Neonatal Care. 2009 Feb;9(1):34-9. doi: 10.1097/01.ANC.0000346094.28110.11.
• te Pas AB, Lopriore E, Dito I, Morley CJ, Walther FJ. Humidified and heated air during stabilization at birth improves temperature in preterm infants. Pediatrics. 2010 Jun;125(6):e1427-32. doi: 10.1542/peds.2009-2656. Epub 2010 May 10.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pro00051454