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New blood test may spot brain damage in newborns faster

NCT ID NCT05986994

Diagnosis Sponsor: Ospedale Buon Consiglio Fatebenefratelli 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether tiny molecules called microRNAs, found in the blood, can help diagnose brain injury in newborns who had a lack of oxygen at birth. Researchers measured microRNA levels in 45 newborns, including healthy babies and those with brain injury. The goal was to see if these molecules could serve as reliable biomarkers to guide treatment decisions, such as which babies need cooling therapy.

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 to help doctors quickly diagnose brain injury in newborns and decide on the best treatment.
What could go wrong
This was a small, completed study with only 45 newborns. More research is needed to confirm if microRNAs are reliable enough for routine use.

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

45 people

The number who actually took part.

Started

Jul 2023

Finished

Sep 2024

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

All patients transferred to the Buon Consiglio Fatebenefratelli hospital will be eligible

Ages

35 to 42 weeks

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: * newborns with at least 35 weeks of gestational age * body weight of at least 1800 g Exclusion Criteria: * Withdrawal of informed consent

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Conditions

The condition(s) this trial relates to.

Asphyxia brain disorder brain hypoxia - ischemia Hypothermia perinatal asphyxia

As listed by the trial registrant

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

Asphyxia perinatal Hypoxic-ischemic encephalopathy

Contacts and locations

Locations

  • Department of Neuroscience, Reproductive and Dentistry Sciences, University of Naples Federico II

    Naples, 80131, Italy

  • Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital

    Naples, 80123, Italy

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