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Newborn Screening for Spinal Muscular Atrophy: A Pilot Study in Thailand

Newborn Screening for Spinal Muscular Atrophy: A Pilot Study in Thailand

Status
Unknown
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20240716007
Enrollment
20000
Registered
2024-07-16
Start date
2023-12-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary objective To analyze rate of Thai SMA patients identified by melting curve-based assay of 20,000 Dried Blood Spot (DBS) samples collected in Expanded Newborn Screening from hospitals in Bangkok area sent to Siriraj hospital. Primary endpoint Incidence of Thai patients with positive screening test for SMA Newborn screening, Spinal muscular atrophy, SMA newborn screenings, NBS

Interventions

NBS samples will be collected following the instructions of the ENS project . In summary, NBS samples will be collected on filter paper Whatman S&amp
S 903 after 48 hours of life and will be breastfed for 4-6 meals. If mother is discharged before 48 hours, NBS samples could be collected. Blood sampling could be taken from heel or dorsal hand vein.
Screening
Thai newborns screening

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
24 Hours to 48 Hours

Inclusion criteria

Inclusion criteria: Thai newborns in participating hospitals during the inclusion period.

Exclusion criteria

Exclusion criteria: Newborns whose parents or legally acceptable representatives do not sign informed consent form to participate in the study.

Design outcomes

Primary

MeasureTime frame
SMN1 exon 7 deletion and SMN2 copy number (where performed) The DBS cards will be sent to and analyzed at Siriraj Hospital within 2 days. NBS samples will be collected following the instructions of the ENS

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactSurachai Likasitwattanakul

Faculty of Medicine Siriraj Hospital, Mahidol University

surachai.lik@mahidol.ac.th0894544337

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026