Viewing Study NCT02123186



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Last Modification Date: 2024-10-26 @ 11:23 AM
Study NCT ID: NCT02123186
Status: COMPLETED
Last Update Posted: 2016-11-02
First Post: 2014-04-21

Brief Title: Newborn Screening for Spinal Muscular Atrophy
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Newborn Screening for Spinal Muscular Atrophy
Status: COMPLETED
Status Verified Date: 2016-04
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: None
Brief Summary: To test if the routine newborn screening dried blood spots can be used to test if missing 2 copies of SMN1 gene a status indicating spinal muscular atrophy
Detailed Description: Parents of newborns will be invited to test if their newborns are affected with SMA The routine newborn screening dried blood spots sample will be used to test if missing 2 copies of SMN1 gene If positive of screening test further confirmation tests including physical examination and other methology for SMN1 gene copies quantification will be provided Genetic counseling and treatment option will be provided too

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None