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Gene test for newborns: could it spot hidden diseases?

NCT ID NCT05476640

Knowledge-focused Sponsor: Shanghai Children's Hospital 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to see if targeted gene sequencing could improve newborn disease screening compared to standard methods. Over 3,300 newborns were tested, but the study was terminated early. The goal was to measure how well the genetic test agreed with routine screening results.

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 show that genetic sequencing is a useful addition to standard newborn screening, helping detect more conditions early.
What could go wrong
The study was terminated early, so results are limited. It is an observational comparison, not a treatment trial, and may not change practice.

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

3,348 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2024

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

All newborns are our targeted population.

Ages

1 day to 28 days

Sex

Anyone

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: * \-- Subjects: all newborns (from birth to 28 days); * \-- After fully understanding the program, the guardian signs the informed consent and agrees to participate in the program. Exclusion Criteria: * Other similar clinical research projects are under way for the examined neonates; * Neonates have received transfusion of allogeneic blood products; * Newborns whose guardians explicitly refuse to participate in the program after receiving the mission. Elimination criteria * Samples that are not properly collected or stored for testing; * Samples with non-standard data records; * Samples without clinical follow-up results; * The project recalls newborns who are required to withdraw by their guardians during the follow-up.

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As listed by the trial registrant

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

Newborns

Contacts and locations

Locations

  • Shanghai Children's hospital

    Shanghai, 200062, China

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