NCT05368038
MPS VI, MPS IVA, CLN2, Mucopolysaccharidosis II, Niemann-Pick Disease, Type C, Mucopolysaccharidosis VII, Mucopolysaccharidosis VI, Mucopolysaccharidosis IV A, Mucopolysaccharidosis III-B, Acid Sphingomyelinase Deficiency, Metachromatic Leukodystrophy, Lysosomal Acid Lipase Deficiency, Gaucher Disease, GM1 Gangliosidosis, Fabry Disease, Cerebrotendinous Xanthomatosis, Ceroid Lipofuscinosis, Neuronal, 2
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
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 newborn(s) screened for a panel of additional conditions. The study has three primary objectives: 1) define the analytic and clinical validity of multi-tiered screening assays for a flexible panel of disorders, 2) determine disease incidence in an ethnically diverse population, and 3) assess the impact of early diagnosis on health outcomes. Over a five-year period, ScreenPlus aims to screen 100,000 infants born in nine high birthrate, ethnically diverse pilot hospitals in New York for a flexible panel of 14 rare genetic disorders. This study will also involve an evaluation of the Ethical, Legal and Social issues pertaining to NBS for complex disorders, which will be done via online surveys that will be directed towards ScreenPlus parents who opt to participate and qualitative interviews with families of infants who are identified through ScreenPlus.
All
Up to 4 Weeks
Yes
Confirmatory Testing
Observational
100000
2021-05-10
2024-09-19
Bronx, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Brooklyn, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Queens, New York, United States
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