ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program

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Trial Status Enrolling By Invitation

Trial Identifier

NCT05368038

Condition

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.

Trial 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 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.

Eligibility Criteria

Birth Sex

All

Age

Up to 4 Weeks

Healthy Volunteers

Yes

Drug/Treatment:

Confirmatory Testing

Study Type:

Observational

Number of Participants:

100000

Study Started:

2021-05-10

Study Updated:

2024-09-19

Trial Locations

  • Jack D. Weiler Hospital

    Bronx, New York, United States

  • ScreenPlus Coordinating Core, Children's Hospital at Montefiore

    Bronx, New York, United States

  • Maimonides Medical Center

    Brooklyn, New York, United States

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, United States

  • North Shore University Hospital

    Manhasset, New York, United States

  • NYU Langone Health - Tisch Hospital

    New York, New York, United States

  • Mount Sinai West

    New York, New York, United States

  • Mount Sinai Hospital

    New York, New York, United States

  • Long Island Jewish Medical Center

    Queens, New York, United States

Inclusion Criteria

  • 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 Criteria

  • A newborn screening sample is unavailable
  • Infants who are more than four weeks ol

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