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Can a routine blood count signal sepsis in premature babies?

NCT ID NCT07821190

Diagnosis Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Preterm babies face a serious risk of late-onset sepsis, an infection that can be hard to diagnose quickly. This study checks whether monocyte distribution width, a measurement taken from a standard blood count, can accurately identify which preterm babies have the infection. Researchers will measure it in 60 preterm newborns when doctors first suspect sepsis, then compare the results with confirmed blood cultures to see how well the measure performs.

What this could mean

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

Active substance
monocyte distribution width measurement from a routine blood count
What this could lead to
If it works, this could give doctors a faster, simpler way to spot late-onset sepsis in preterm babies, using a measurement from a blood count they already order.
What could go wrong
This is a small, single-center study of 60 babies, so the results may not hold up in larger or more varied groups. A biomarker test can also miss cases or raise false alarms, and it cannot replace confirming an infection with a culture.

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 60 people

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

Started

Jul 2026

Expected to finish

Jul 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

A total of 60 preterm neonates with clinical suspicion of late-onset neonatal sepsis (LONS) will be included. All eligible neonates admitted to the Neonatal Intensive Care Unit (NICU) of the Pediatrics Department, Tanta University Hospitals, will be screened, and those meeting the inclusion criteria will be enrolled consecutively at the time of first clinical suspicion of sepsis

Ages

73 hours 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:The study will include: 1. Preterm neonates with gestational age \<37 weeks. 2. Neonates aged \>72 hours of life at the time of enrollment. 3. Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following: * Temperature instability (core temperature \>38°C or \<36°C) * Respiratory distress or new-onset apnea * Feeding intolerance or poor feeding * Lethargy or irritability * Bradycardia or tachycardia * Hypotension * Unexplained clinical deterioration Exclusion Criteria: * Neonates with any of the following will be excluded from the study: 1. Early onset neonatal sepsis. 2. Major congenital anomalies 3. Chromosomal abnormalities 4. Metabolic disorders 5. Severe perinatal asphyxia 6. Neonates with surgical conditions

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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.

Late onset neonatal sepsis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Faculty of Medicine, Tanta University

    RECRUITING

    Tanta, Egypt

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