Status:
ENROLLING_BY_INVITATION
ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Alexion Pharmaceuticals, Inc.
Conditions:
Acid Sphingomyelinase Deficiency
Ceroid Lipofuscinosis, Neuronal, 2
Eligibility:
All Genders
Up to 4 years
Brief Summary
ScreenPlus is a consented, multi-disorder pilot newborn screening program implemented in conjunction with the New York State Newborn Screening Program that provides families the option to have their n...
Detailed Description
Soon after birth, all babies born in the United States have a newborn screening (NBS) test to check for certain medical conditions. All babies are screened, even if they appear healthy, because most o...
Eligibility Criteria
Inclusion
- All newborn infants born at a ScreenPlus pilot hospital
- Infants who are less than four weeks old, regardless of sex, gestational age, or health status.
Exclusion
- A newborn screening sample is unavailable
- Infants who are more than four weeks old
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
100000 Patients enrolled
Trial Details
Trial ID
NCT05368038
Start Date
May 10 2021
End Date
August 31 2029
Last Update
September 12 2025
Active Locations (9)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
2
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States, 11220
3
North Shore University Hospital
Manhasset, New York, United States, 11030
4
NYU Langone Health - Tisch Hospital
New York, New York, United States, 10016