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New blood test may predict brain damage in Oxygen-Deprived newborns

NCT ID NCT07292220

Knowledge-focused Sponsor: Mustafa Gürkan 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a protein called neurofilament light chain (NfL) in the blood can help measure brain injury in newborns with hypoxic-ischemic encephalopathy (HIE), a condition caused by lack of oxygen at birth. Researchers will measure NfL levels at several time points in 20 babies undergoing cooling therapy and compare them to healthy newborns. The goal is to see if NfL can serve as a reliable marker for injury severity and recovery.

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 helps doctors predict how severe a newborn's brain injury is and guide treatment decisions.
What could go wrong
This is a very small, early study with only 20 participants. It is designed to gather information, not to test a treatment, so it may not lead to any immediate changes in care.

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 20 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 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

Cases admitted to the Neonatal Intensive Care Unit of Kırıkkale University Faculty of Medicine Hospital with a diagnosis of hypoxic-ischemic encephalopathy (HIE) and started on therapeutic hypothermia (TH) treatment were prospectively recorded.

Ages

0 to 28 days

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: 1. Newborns with a gestational age ≥36 weeks (term) 2. Diagnosis of hypoxic ischemic encephalopathy (HIE) based on clinical and/or laboratory findings 3. Diagnosis of stage I, stage II, or stage III HIE according to the Sarnat staging system 4. Therapeutic hypothermia (TH) treatment initiated within the first 6 hours after birth 5. Written consent obtained from the legal parent(s) for participation in the study Exclusion Criteria: 1. Major congenital malformation or genetic syndrome (e.g., Trisomy 21, congenital heart disease) 2. Newborns with suspected sepsis, metabolic disease, or other systemic disease 3. Premature infants with a gestational age \<36 weeks 4. Therapeutic hypothermia treatment not started on time or inadequately administered 5. Medical conditions preventing blood sampling (e.g., severe coagulopathy, circulatory instability)

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia Charcot-Marie-Tooth disease type 1F perinatal asphyxia

As listed by the trial registrant

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

Hypoxic-ischemic encephalopathy

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • , Kirikkale University, Department of Pediatrics, Kirikkale

    Kirikkale, Yahşihan, 71450, Turkey (Türkiye)

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