About this trial
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
This trial accepts healthy volunteersQualifiers
Neonates born in Taiwan who receive regular newborn screening suggested by Ministry of Heath and Welfare.
Parents or legal guardian agree to perform SMA newborn screening.
Disqualifiers
None
Trial population
Neonates whose parents agree to be tested.
Trial design
Cohort
Prospective
Treatments tested in this trial
SMA Newborn Screening
Other intervention
Treatment groups
Trial outcomes
Primary outcomes
Number of neonates with confirmed the deletion of 2 copies of SMN1 gene
Neonates with positive SMA newborn screening will be confirmed by multiplex ligation-dependent probe amplification (MLPA) test
Secondary outcomes
Number of neonates with confirmed SMA
Neonates with confirmed the deletion of 2 copies of SMN1 gene by MLPA test will be followed till SMA symptoms appear.
Sponsors and contacts
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead sponsor
The Chinese Foundation of Health
Collaborator
Taipei Institute of Pathology
Collaborator