Clinical Research Directory
Browse clinical research sites, groups, and studies.
ScreenPlus: A Comprehensive, Flexible, Multi-disorder Newborn Screening Program
Sponsor: Albert Einstein College of Medicine
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 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.
Key Details
Gender
All
Age Range
Any - 4 Weeks
Study Type
OBSERVATIONAL
Enrollment
100000
Start Date
2021-05-10
Completion Date
2029-08-31
Last Updated
2025-09-12
Healthy Volunteers
Yes
Conditions
Interventions
Confirmatory Testing
All positive screens will be referred using standard notification procedures, where the New York State NBS reporting team contacts the ScreenPlus site medical geneticist, who will contact the newborn's pediatrician and family. The initial evaluation will include a clinical examination and confirmatory molecular studies, enzymatic and biomarker studies, when available. All aspects of the confirmatory testing will be at no cost to the participants. If confirmed to have a ScreenPlus disorder, the investigators will counsel the family and help connect them with treatment, clinical trials and disease specialists. The investigators will also provide emotional and social support resources to help in this journey.
Locations (9)
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
Jack D. Weiler Hospital
The Bronx, New York, United States
ScreenPlus Coordinating Core, Children's Hospital at Montefiore
The Bronx, New York, United States