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

Body Temperature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311972
• Other study ID #: Pro00051454
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: September 26, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Temperature

Intervention

Device:
• Philips InnerSense Esophageal Temperature Sensor/Feeding Tube

• Standard of care feeding tube

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Philips Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Feb 12. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Primary	mean axillary admission temperature	Mean axillary temperatures from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference is seen over the first 24 hours of life.	Admission through first 24 hours of infant life.	No
Primary	mean axillary temperature	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.	First 4 hours of infant life.	No
Secondary	percentage of infants with hypothermic temperatures (<36.5° C)	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	No
Secondary	percentage of infants with hypothermic temperatures (<36.5° C)	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	No
Secondary	percentage of infants with hypothermic temperatures (<36.5° C)	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	No
Secondary	percentage of infants with hypothermic temperatures (<36.5° C)	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	No
Secondary	relationship of minute to minute temperatures, as measured by correlation coefficient	Measuring temperatures from abdomen thermistor with esophageal temperatures in each infant, in intervention group only.	First 24 hours of infant life.	No