Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
Running, not enrolling
Conditions studied: Neonatal SEPSIS
In brief
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 facts
- Study ID
- NCT03291496
- Run by
- University of Florida
- People needed
- 293
- Starts
- 2017-11-14
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-13
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UF Health — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.