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A drop of cord blood at birth could flag a rare condition that harms infant brains

NCT ID NCT07795047

Diagnosis Sponsor: Odense University Hospital 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.
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether measuring glucose in umbilical cord blood, already collected at birth, can screen newborns for congenital hyperinsulinism, a condition that causes dangerously low blood sugar and can lead to brain damage if missed. Researchers will check the test's accuracy in about 50 newborns and follow up with infants who screen positive, using developmental tests, EEG, and MRI at 6 months. The goal is to see if this simple, non-invasive test can catch the condition early enough to prevent long-term harm.

What this could mean

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

Active substance
Umbilical cord blood glucose measurement as a screening test
What this could lead to
If it works, this could lead to a simple, routine screening test at birth that catches congenital hyperinsulinism early and prevents brain damage in affected infants.
What could go wrong
The trial is early and small, and the screening threshold may not prove accurate across all newborns. False positives or negatives could limit its usefulness, and follow-up is only at 6 months.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 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

Aug 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.

Ages

Up to 8 months

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: Study 2: * Live-born neonates delivered at participating Danish hospitals during the study period. * arterial umbilical cord blood glucose (UCBG) ≤3.5 mmol/L. * Written informed consent obtained from parent(s) or legal guardian(s). Study 3: * Infants diagnosed with pathological neonatal hyperinsulinism (HI) following UCBG screening in Study 2. * Written informed consent obtained from parent(s) or legal guardian(s) for participation in the follow-up study. Exclusion Criteria: Study 2: * No predefined clinical exclusion criteria. * Missing or unsuccessful arterial umbilical cord blood sampling resulting in an unavailable UCBG measurement. * Withdrawal of parental consent. Study 3: * No predefined clinical exclusion criteria. * Withdrawal of parental consent.

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Conditions

The condition(s) this trial relates to.

Congenital Hyperinsulinism familial hyperinsulinism hyperinsulinism

As listed by the trial registrant

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

Congenital hyperinsulinism (CHI)

How to take part

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  1. The official record

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  2. A doctor treating you

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