Status:
RECRUITING
A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
University Hospital, Caen
Conditions:
Neonatal Screening
Lysosomal Storage Diseases
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected. Based on our previous pilot study (2011) a...
Eligibility Criteria
Inclusion
- Newborn in a Normandy maternity hospital
- Newborn participating in the National Neonatal Screening Program
- Holder(s) of parental authority having read and understood the information letter and signed the informed consent form
Exclusion
- There are no criteria for non-inclusion in this study. Participation in the study, such as participation in the National Neonatal Screening Program, is not mandatory.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2026
Estimated Enrollment :
100000 Patients enrolled
Trial Details
Trial ID
NCT04393701
Start Date
March 8 2021
End Date
December 8 2026
Last Update
September 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Caen University Hospital
Caen, France
2
Rouen University Hospital
Rouen, France