TerminatedNot Applicable

Newborn Sequencing Screening in China

Stopped: The sponsor is short of funds.

China3,348 participantsStarted 2022-09-20

Plain-language summary

The project will carry out the genetic testing of 10000 neonates. The aim of the project is to assess the application of targeted sequencing technology in the screening of neonatal diseases.

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Outcome measure

Timeframe: From enrollment to the end of test at 3 years

Trial details

NCT IDNCT05476640

SponsorShanghai Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Newborns trials

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.