CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 293 enrolled
Drug / intervention
Blood Collection Preterm +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03291496
NCT03291496N/AActive

Microfluidic Assessment of Clinical Outcomes in Preterm Newborns

University of Florida·observational·Posted Sep 25, 2017·Updated Feb 13, 2026

In Brief

An observational study evaluating Blood Collection Preterm, Blood Collection Term, and 1 other intervention for Neonatal SEPSIS. Active but no longer recruiting, targeting 293 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal SEPSIS
CountriesUnited States

Timeline

N/AActive
2018201920202021202220232024202520262027
First PostedSep 25, 2017
Enrollment StartNov 14, 2017
Primary CompletionMay 10, 2022
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.8 years ago

Interventions

Blood Collection Pretermother

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 Termother

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

Adult Blood collectionother

One Time 1 ml of whole blood collected