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Quick blood tests could save newborns from sepsis

NCT ID NCT07663084

Diagnosis Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study explores whether routine blood tests—like CBC and lactate levels—can help doctors diagnose sepsis in newborns more quickly than waiting 2-3 days for a blood culture. Researchers will enroll 80 infants in the NICU with signs of infection and compare these rapid test results to standard methods. The goal is to find faster, life-saving clues for treatment.

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 give doctors a fast, cheap way to spot sepsis in newborns earlier, leading to quicker treatment and better outcomes.
What could go wrong
This is a small, early observational study (80 infants) that only looks at test accuracy, not treatment. The markers may not be reliable enough to replace standard methods.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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

The study population will consist of term and preterm neonates, aged 0 to 28 days, who are admitted to the Neonatal Intensive Care Unit (NICU) at the Pediatrics Department of Assiut University Children Hospitals in Assiut, Egypt. Eligible participants must present with two or more clinical signs highly suggestive of sepsis, such as temperature instability, tachycardia or bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone. Neonates with severe congenital anomalies, chromosomal abnormalities, inborn errors of metabolism, severe perinatal asphyxia, or those who have received prior broad-spectrum intravenous antibiotics for more than 24 hours, prior blood transfusions, or require immediate surgical intervention will not be included in the study.

Ages

0 to 28 days

Sex

Anyone

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: * Neonates aged 0 to 28 days (term and preterm). * Presence of two or more clinical signs highly suggestive of sepsis (e.g., temperature instability \[\< 36.5°C or \> 37.5°C\], tachycardia/bradycardia, tachypnea, feeding intolerance, lethargy, or altered muscle tone). * Informed written consent obtained from the parents or legal guardians. Exclusion Criteria: * Neonates with severe congenital anomalies or chromosomal abnormalities. * Neonates diagnosed with Inborn Errors of Metabolism (which inherently alter lactate levels). * Neonates with severe perinatal asphyxia or Hypoxic-Ischemic Encephalopathy (HIE), as these conditions cause profound primary lactic acidosis independent of sepsis. * Neonates who received prior broad-spectrum intravenous antibiotics for more than 24 hours prior to admission. * Neonates who have received prior blood transfusions. * Neonates requiring immediate surgical intervention.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis neonatal sepsis Sepsis

As listed by the trial registrant

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

Neonatal sepsis Sepsis

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

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