Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
NCT ID: NCT02311972
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2014-11-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Standard of care feeding tube
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.
Philips InnerSense Esophageal Temperature Sensor/Feeding Tube
Interventions
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Philips InnerSense Esophageal Temperature Sensor/Feeding Tube
Standard of care feeding tube
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Infants are not eligible if they have major congenital anomalies including gastrointestinal or facial abnormalities
* Infants with major cardiac anomalies are also excluded
1 Minute
24 Hours
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Robin B Dail (Knobel), PhD, RN, FAAN
Role: PRINCIPAL_INVESTIGATOR
Duke University School of Nursing & School of Medicine, Department of Pediatrics
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Pro00051454
Identifier Type: -
Identifier Source: org_study_id
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