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

Status: Enrolling_by_invitation
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
Maimonides Medical Center
Brooklyn
NYU Langone Hospital - Brooklyn
Brooklyn
North Shore University Hospital
Manhasset
Mount Sinai Hospital
New York
Mount Sinai West
New York
NYU Langone Health - Tisch Hospital
New York
Long Island Jewish Medical Center
Queens
Jack D. Weiler Hospital
The Bronx
ScreenPlus Coordinating Core, Children's Hospital at Montefiore
The Bronx
Time Frame
Start Date: 2021-05-10
Completion Date: 2029-08-31
Participants
Target number of participants: 100000
Treatments
Newborn infants born at a ScreenPlus pilot hospital
Parents who give permission will have their infant's sample screened for the ScreenPlus panel. Infants who screen positive after multi-tiered testing will be referred to a ScreenPlus doctor for confirmatory testing and care coordination.
Sponsors
Collaborators: Dana's Angels Research Trust (DART), Genzyme, a Sanofi Company, Mirum Pharmaceuticals, Inc., Takeda Pharmaceuticals North America, Inc., Cure Sanfilippo Foundation, New York State Department of Health, Case Western Reserve University, Sio Gene Therapies, The FireFly Fund, Alexion Pharmaceuticals, Inc., The Noah's Hope - Hope 4 Bridget Family Foundations, BioMarin Pharmaceutical, Passage Bio, Inc., Orchard Therapeutics, Travere Therapeutics, Inc., Ara Parseghian Medical Research Fund, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ultragenyx Pharmaceutical Inc
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov