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Tiny blood test could predict deadly sepsis in preterm infants

NCT ID NCT03291496

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new microfluidic device that uses a very small blood sample to measure how well immune cells (neutrophils) function in premature newborns. The goal is to see if this test can predict which babies will develop sepsis, a life-threatening infection. Researchers will collect blood from 293 preterm and term infants, as well as healthy adults, to compare results and identify early warning signs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that predicts sepsis in premature babies before symptoms appear, potentially saving lives and reducing long-term health problems.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove accurate enough for routine use, and results may not apply to all hospitals or newborn populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

293 people

The number who actually took part.

Started

Nov 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Preterm neonates \<32 weeks gestation. Term neonates \>36 weeks gestation.

Ages

23 to 42 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal sepsis

Contacts and locations

Locations

  • UF Health

    Gainesville, Florida, 32610, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.