Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03217578
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2017-07-12
Brief Title:
Neonatal Spinal Muscular Atrophy SMA Screening
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
Study on the Neonatal Screening of Spinal Muscular Atrophy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMA
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None