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Sepsis in newborns: the hidden brain signs doctors may be missing

NCT ID NCT07813689

Knowledge-focused Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)
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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

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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at Assiut University Children Hospital observe newborns diagnosed with sepsis to record any neurological signs that appear. The study follows 100 newborns aged 0 to 28 days, both full-term and preterm, who are admitted to the neonatal intensive care unit. Investigators note the types of neurological signs, along with the clinical and laboratory features of babies with and without them. The goal is to describe how often and in what forms these signs show up.

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 researchers map which neurological signs appear in newborns with sepsis, doctors could spot brain involvement earlier and target care sooner.
What could go wrong
This is an observational study, so it cannot prove that sepsis causes any particular neurological sign. Findings from one hospital's newborns may not apply to other settings.

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 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 will include neonates diagnosed with neonatal sepsis who are admitted to the NICU during the study period.

Ages

Up to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 0-28 days ( both fullterm and preterm neonates). * Diagnosed with neonatal sepsis. * Admitted to the NICU during the study period. Exclusion Criteria: * Neonates with major congenital anomalies of the central nervous system. * Neonates with hypoxic-ischemic encephalopathy. * Neonates with confirmed inborn errors of metabolism. * Neonates with chromosomal abnormalities.

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Conditions

The condition(s) this trial relates to.

neonatal sepsis Sepsis

As listed by the trial registrant

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

Neurological menfestions in neonatal sepsis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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