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Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Sponsor: University of Florida
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 the most common, difficult and costly problems to diagnose, treat and prevent. The preterm infant can suffer rates of sepsis up to 1000-fold higher than the full-term infant, and bears the brunt of the associated mortality and lifelong sepsis-survivor morbidity. The project is enabled by several novel, validated, microfluidic technologies that are robust and easy to use with little training. These technologies provide comprehensive measures of the functionality of blood PMN population; a critical cellular component of innate immunity. The study team will also extract high-quality nucleic acids from microfluidic-sorted PMNs for transcriptomic analyses. Collectively, these techniques require a total of 250 microliters (µL) of blood, which makes them particularly useful for preterm infants where sample volume is limited, and facilitates serial assessments with unprecedented temporal resolution of key functions of PMNs. These studies, integrated with bioinformatics approaches, will generate new tools for diagnosing sepsis in the newborn and predicting clinical outcomes. Such approaches have the capability to dramatically change the clinical management of the preterm infant, and potentially improve long-term outcomes while reducing hospital costs.
Key Details
Gender
All
Age Range
23 Weeks - 42 Weeks
Study Type
OBSERVATIONAL
Enrollment
293
Start Date
2017-11-14
Completion Date
2026-12-31
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
Blood Collection Preterm
Blood will be collected on day 4 of life and then approximately every 3 days until 21 days of life. Thereafter, one sample will be collected weekly until discharge. For preterm neonates that have suspected sepsis an additional sample will be collected within 24-48 hours of the initial sepsis evaluation.
Blood Collection Term
A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.
Adult Blood collection
One Time 1 ml of whole blood collected
Locations (1)
UF Health
Gainesville, Florida, United States