Status:
COMPLETED
Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Lead Sponsor:
Duke University
Collaborating Sponsors:
Philips Healthcare
Conditions:
Body Temperature
Eligibility:
All Genders
1-24 years
Phase:
NA
Brief 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 inabilit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02311972
Start Date
November 1 2014
End Date
June 1 2016
Last Update
June 14 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710