Sun May Arise on SMA : Newborn Screening of Spinal Muscular Atrophy in Belgium
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03554343 |
Recruitment Status :
Recruiting
First Posted : June 13, 2018
Last Update Posted : May 28, 2020
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Condition or disease | Intervention/treatment |
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Spinal Muscular Atrophy | Diagnostic Test: test for SMN1 exon 7 deletion |
Study Type : | Observational |
Estimated Enrollment : | 180000 participants |
Observational Model: | Ecologic or Community |
Time Perspective: | Prospective |
Official Title: | Sun May Arise on SMA : Newborn Screening of SMA in Belgium |
Actual Study Start Date : | March 5, 2018 |
Estimated Primary Completion Date : | March 4, 2021 |
Estimated Study Completion Date : | July 31, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
All newborn from Southern Belgium
All newborns except newborns for which parents refuse newborn screening will be tested for exon 7 deletion in survival motor neuron 1 (SMN1)
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Diagnostic Test: test 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 |
- Cases detected [ Time Frame: march 2018-March 2021 ]Number of cases detected, false negative and false positive cases
- Incidence of SMA [ Time Frame: March 2018-March 2021 ]to gather epidemiological data on SMA in Wallonia-Brussels Federation (carrier frequency, number of cases/year).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 7 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All newborns in southern Belgium
Exclusion Criteria:
- Newborns whose parents refuse screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554343
Contact: Laurent Servais, MD, PhD | +3243216127 | laurent.servais@paediatrics.ox.ac.uk |
Belgium | |
CRMN, Hôpital La Citadelle | Recruiting |
Liege, Wallonia, Belgium, 4000 | |
Contact: Laurent Servais, MD, PhD +3243216127 laurent.servais@paediatrics.ox.ac.uk | |
Contact: Tamara Dangouloff +33662438138 tdangouloff.screeningsma@gmail.com | |
Sub-Investigator: Jean-Hubert Caberg, PhD | |
Sub-Investigator: Francois Boemer, PhD |
Principal Investigator: | Laurent Servais, MD, PhD | CRMN |
Responsible Party: | Laurent Servais, Professor, Centre Hospitalier Régional de la Citadelle |
ClinicalTrials.gov Identifier: | NCT03554343 |
Other Study ID Numbers: |
B412201734396 |
First Posted: | June 13, 2018 Key Record Dates |
Last Update Posted: | May 28, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
newborn screening |
Muscular Atrophy Muscular Atrophy, Spinal Atrophy Pathological Conditions, Anatomical Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Spinal Cord Diseases Central Nervous System Diseases Motor Neuron Disease Neurodegenerative Diseases Neuromuscular Diseases |