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Breath test could help prevent brain damage in jaundiced newborns

NCT ID NCT06832800

Disease control Sponsor: Women's Hospital School Of Medicine Zhejiang University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a new method to diagnose and treat severe jaundice in newborns. The method uses a non-invasive breath test (ETCOc) to detect hemolysis, a common cause of jaundice. Researchers will compare this approach to standard care in 250 newborns to see if it reduces the risk of brain damage by age one.

What this could mean

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

Active substance
modified diagnosis and treatment (MDT) method including ETCOc measurement
What this could lead to
If it works, this could lead to a better way to prevent brain damage in newborns with severe jaundice.
What could go wrong
This is a very early (Phase 1) trial with only 250 participants, so results may not be conclusive. The new method may not prove better than current 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.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 250 people

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

Started

Jul 2025

Expected to finish

Dec 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.

Ages

4 hours to 28 days

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: Inclusion Criteria: Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams * Infants with severe neonatal hyperbilirubinemia, including those whose serum total * bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL). Exclusion Criteria: * Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Hyperbilirubinemia, Neonatal transient familial neonatal hyperbilirubinemia

As listed by the trial registrant

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

Neonatal hyperbilirubinemia

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

  • Women's Hospital School of Medicine Zhejiang University

    RECRUITING

    Hangzhou, China

More trials for these conditions

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