Status:
ACTIVE_NOT_RECRUITING
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Neonatal SEPSIS
Eligibility:
All Genders
23-42 years
Brief Summary
Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis (sepsis within the first month of life) causes over one million deaths worldwide annually, and is one of th...
Detailed Description
Blood samples will be collected from two populations: preterm infants and term infants. 1. Preterm neonates (\<32 weeks) the study team will collect a baseline 250 µl blood sample on day four of life...
Eligibility Criteria
Inclusion
- For preterm neonates \<32 weeks gestation at birth with no known or suspected congenital anomalies.
- For term neonates \>36 weeks gestation at birth with no known or suspected congenital anomalies.
Exclusion
- Congenital defects, suspected genetic disorders, 32-36 weeks completed gestation, or lack of consent.
- Healthy Adult:
- Inclusion criteria Between the ages of 18 and 65 years of age
- Exclusion Criteria Taking any immune modifying medications or have an active immune modifying disease process
Key Trial Info
Start Date :
November 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT03291496
Start Date
November 14 2017
End Date
December 31 2025
Last Update
April 22 2025
Active Locations (1)
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1
UF Health
Gainesville, Florida, United States, 32610