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A drop of blood could spot a deadly liver disease in newborns

NCT ID NCT03898765

Diagnosis Sponsor: Xinhua Hospital, Shanghai Jiao Tong 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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial is testing whether a dry blood spot test—using a tiny sample from a newborn's heel—can screen for biliary atresia, a serious liver condition that blocks bile flow. The test measures certain biomarkers (direct bilirubin, γ-GT, and MMP-7) that may be elevated in affected babies. The goal is to enable earlier diagnosis and treatment, which could improve survival. The study will include newborns born in Shanghai.

What this could mean

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

Active substance
Dry blood spot screening measuring biomarkers (direct bilirubin, γ-GT, MMP-7)
What this could lead to
If successful, this could lead to a routine newborn screening test that catches biliary atresia early, potentially saving lives through timely surgery.
What could go wrong
This is an early-stage diagnostic study, and the test may not be accurate enough for widespread use. False positives or negatives could occur, and more research is needed before it becomes standard.

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.

Expected to start

Apr 2019

An estimate. Start dates often move.

Finished

Dec 2021

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Neonates born in Shanghai Exclusion Criteria: * Subjects who do not agree with study protocol * Subjects who join other clinical trials

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Conditions

The condition(s) this trial relates to.

biliary atresia Digestive System Diseases hepatobiliary disorder

As listed by the trial registrant

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

Biliary atresia Hepatobiliary disease Neonatal cholestasis

Contacts and locations

Locations

  • Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine

    Shanghai, China

More trials for these conditions

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