Status:
COMPLETED
AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring
Lead Sponsor:
AION Biosystems
Conditions:
Fever
Sepsis
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate the effectiveness of the AION BIOSYTEMS, INC. tempshield ("Shield") temperature monitoring device and platform in detecting body temperature for child...
Detailed Description
A prospective, single site, interventional study assessing the effectiveness for use of the non-invasive wireless temperature monitoring device and platform in detecting body temperature of young chil...
Eligibility Criteria
Inclusion
- Male or female patients between ages 1 years - 4 years of age
- Confirmed oral temperature of \>=99.5 F for febrile participants
- Willing and likely (based on the investigator's judgement) to comply with all study requirements
Exclusion
- Participants who are allergic to silicone
- Adolescents with sensory issues who may find it difficult to have a wearable device on their chest.
- Participants presenting an anatomical limitation that would prevent the use of the wearable device
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07145541
Start Date
January 31 2024
End Date
October 10 2024
Last Update
November 19 2025
Active Locations (1)
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1
Children's Hospital
Washington D.C., District of Columbia, United States, 20010