Screens newborns for several rare inherited diseases in New York hospitals
Offers optional extra screening of newborns for rare genetic diseases, including Fabry disease.
Plain-language title generated from the registry record
Registry title: ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Key facts
- Where
- Brooklyn, Manhasset, New York, Queens, and The Bronx, United StatesSee the 9 sites
Where in United States
- Maimonides Medical CenterBrooklyn, United StatesNo longer taking part
- NYU Langone Hospital - BrooklynBrooklyn, United StatesNo longer taking part
- North Shore University HospitalManhasset, United StatesNo longer taking part
- Mount Sinai HospitalNew York, United StatesNo longer taking part
- Mount Sinai WestNew York, United StatesNo longer taking part
- NYU Langone Health - Tisch HospitalNew York, United StatesNo longer taking part
- Long Island Jewish Medical CenterQueens, United StatesNo longer taking part
- Jack D. Weiler HospitalThe Bronx, United StatesNo longer taking part
- ScreenPlus Coordinating Core, Children's Hospital at MontefioreThe Bronx, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Albert Einstein College of Medicine
- Trial code
- NCT05368038
- Record updated
- 28 July 2026
- Original description
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 a large newborn population, and 3) assess the impact of early diagnosis on health outcomes. Over a nine-year period, ScreenPlus aims to screen 100,000 infants born in eight high birthrate hospitals in New York for a flexible panel of rare genetic disorders. This study will also evaluate 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.Read full original descriptionShow less
ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
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 a large newborn population, and 3) assess the impact of early diagnosis on health outcomes. Over a nine-year period, ScreenPlus aims to screen 100,000 infants born in eight high birthrate hospitals in New York for a flexible panel of rare genetic disorders. This study will also evaluate 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.
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.