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New breath test may spot jaundice risk in newborns without needles

NCT ID NCT07346976

Diagnosis Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device that measures carbon monoxide in a newborn's breath to help diagnose jaundice. Jaundice is common in newborns and can be serious if not treated. The device is non-invasive and could replace or reduce the need for blood tests. Researchers will measure breath carbon monoxide levels in 100 healthy full-term infants over their first three days of life to find the best cutoff values for predicting jaundice risk.

What this could mean

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

Active substance
Erythrocyte Life Span Tester (device measuring end-tidal carbon monoxide)
What this could lead to
If successful, this could provide a simple, non-invasive breath test to help doctors diagnose and manage newborn jaundice more accurately.
What could go wrong
This is an early observational study with only 100 infants, so results may not apply to all newborns. The device's reliability and practical benefit are still unproven.

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 100 people

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

Started

Dec 2025

Expected to finish

Jul 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

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 gestational age of ≥ 37 weeks and birth weight of ≥ 2.5 kg; 2. Newborns delivered by either vaginal delivery or cesarean section and with hospital stay of ≥ 3 days. Exclusion Criteria: 1. History of second-hand smoke exposure within 24 hours 2. Parents smoke or are exposed to second-hand smoke.

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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

  • 4th Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Yiwu, Zhejiang, 322000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.