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NCT03291496 · ClinicalTrials.gov registry record
Microfluidic Assessment of Clinical Outcomes in Preterm Newborns
A clinical trial of Neonatal SEPSIS, sponsored by University of Florida.
- Active
- Registry status
- 293
- Enrollment target
- 1
- Study location
NCT03291496 is a study of Neonatal SEPSIS that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 293 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03291496, a study of Neonatal SEPSIS, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- 293 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Blood Collection Preterm
- OTHER Blood Collection Term
- OTHER Adult Blood collection
Study Locations (1)
Florida
- UF Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03291496
The ClinicalTrials.gov registry entry for NCT03291496 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 293 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal SEPSIS appearing as the primary indexed condition, and to 3 interventions - of which Blood Collection Preterm is the first listed.
NCT03291496 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03291496 about?
NCT03291496 is a clinical study titled "Microfluidic Assessment of Clinical Outcomes in Preterm Newborns". 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 ...
What is the current status of trial NCT03291496?
This trial is currently active not recruiting. The enrollment target is 293 participants. The study started on 2017-11-14. Estimated completion is 2026-12-31.
What conditions does trial NCT03291496 study?
This clinical trial studies the following conditions: Neonatal SEPSIS.
What interventions are being tested in trial NCT03291496?
The interventions under investigation include: Blood Collection Preterm (OTHER), Blood Collection Term (OTHER), Adult Blood collection (OTHER).
Who is sponsoring clinical trial NCT03291496?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03291496 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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