Sun May Arise on SMA : Newborn Screening of Spinal Muscular Atrophy in Belgium

Sun May Arise on SMA : Newborn Screening of SMA in Belgium

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03554343

Enrollment

136339

Registered

2018-06-13

Start date

2018-03-05

Completion date

2021-02-28

Last updated

2021-03-10

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

Conditions

Spinal Muscular Atrophy

Keywords

newborn screening

Brief summary

Medico-economic study of Newborn screening of Spinal Muscular Atrophy

Detailed description

The aim of this project is to demonstrate the feasibility and the medico-economic impact of a spinal muscular atrophy neonatal screening in a European country. We propose a 3-year-neonatal screening program in Southern Belgium (Wallonia-Brussels Federation) where there is 59.000 newborns/year, among whom 6 are affected by spinal muscular atrophy.

Interventions

DIAGNOSTIC_TESTtest for SMN1 exon 7 deletion

Newborns are screened for SMN1 exon 7 deletion through standard NBS practice Positive case are promptly referred to reference centers

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

Inclusion criteria

* All newborns in southern Belgium

Exclusion criteria

* Newborns whose parents refuse screening

Design outcomes

Primary

Measure	Time frame	Description
Cases detected	march 2018-March 2021	Number of cases detected, false negative and false positive cases

Secondary

Measure	Time frame	Description
Incidence of SMA	March 2018-March 2021	to gather epidemiological data on SMA in Wallonia-Brussels Federation (carrier frequency, number of cases/year).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026