Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03291496

Microfluidic Assessment of Clinical Outcomes in Preterm Newborns

Sponsor: University of Florida

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

Blood Collection Term

A single 250 µl blood sample will be collected once the term neonate is \>24 hours old.

OTHER

Adult Blood collection

One Time 1 ml of whole blood collected

Locations (1)

UF Health

Gainesville, Florida, United States