NCT03217578 Neonatal Spinal Muscular Atrophy (SMA) Screening
| NCT ID | NCT03217578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Condition | Spinal Muscular Atrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 250,000 participants |
| Start Date | 2017-09-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250,000 participants in total. It began in 2017-09-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Parents or legal guardian of neonates who signed agreement will receive SMA screening test if their neonates are affected with SMA. The dried blood spots of routine newborn screening samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have positive SMA screening test, further confirmation with multiplex ligation-dependent probe amplification (MLPA) test and prospective motor function monitoring including physical and neurological examinations will be proved to make SMA confirmation. For any confirmed SMA patient, genetic counseling and standard of care will be proved.
Eligibility Criteria
Inclusion Criteria: 1. Neonates born in Taiwan who receive regular newborn screening suggested by Ministry of Heath and Welfare. 2. Parents or legal guardian agree to perform SMA newborn screening. Exclusion Criteria: Parents or legal guardian do not agree to perform SMA newborn screening.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03217578 clinical trial?
This trial is open to participants of all sexes, aged 0 Weeks or older, up to 2 Weeks, studying Spinal Muscular Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03217578 currently recruiting?
Yes, NCT03217578 is actively recruiting participants. Contact the research team at wendychoucrn@gmail.com for enrollment information.
Where is the NCT03217578 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT03217578 clinical trial?
NCT03217578 is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. The trial plans to enroll 250,000 participants.