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New study aims to decode healthy newborn brain chemistry

NCT ID NCT07585149

Knowledge-focused Sponsor: University College Cork Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study measures normal levels of brain-specific proteins in healthy full-term newborns. Researchers will analyze blood samples from 150 babies to create a reference range for these proteins. This could help doctors spot brain injuries earlier in the future. No treatment or drug is being tested.

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 help doctors interpret brain injury tests in newborns, leading to earlier diagnosis and treatment.
What could go wrong
This is an observational study, not a treatment trial. It only establishes normal ranges; it does not test any therapy or intervention.

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 150 people

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

Started

Apr 2026

Expected to finish

Jun 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

Healthy term neonates who are due to have routine clinical bloods within their first week of life will be recruited for this study.

Ages

0 to 7 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: * Term neonate (≥37 weeks) * Planned routine venous blood drawn within one week of life * Relevant demographic/clinical information available, including gestational age, day of life, birth weight, sex, race, mode of delivery, and 5-minute Apgar score * Informed parental consent obtained prior to any study procedures Exclusion Criteria: * Pre-term neonates \<37 weeks * Any clinical evidence of neurological/ CNS abnormalities. * NICU admission * Any neonates with Suspected or culture-positive sepsis or meningitis Any known inborn errors of metabolism (IEM). Any known chromosomal abnormalities or any apparent congenital abnormalities * When the relevant demographic/clinical information is not available.

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As listed by the trial registrant

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

Biomarker in early diagnosis Neonatal Reference intervals

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Department of Paediatric and Child Health

    RECRUITING

    Cork, T12 DC4C, Ireland

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