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

Status: Enrolling by invitation
Location: See all (10) 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 an ethnically diverse population, and 3) assess the impact of early diagnosis on health outcomes. Over a five-year period, ScreenPlus aims to screen 175,000 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
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: Accepts Healthy Volunteers
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
Jack D. Weiler Hospital
Bronx
ScreenPlus Coordinating Core, Children's Hospital at Montefiore
Bronx
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
Stony Brook University Hospital
Stony Brook
Time Frame
Start Date: May 10, 2021
Estimated Completion Date: July 31, 2026
Participants
Target number of participants: 175000
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: Alexion, AstraZeneca Rare Disease, Passage Bio, Inc., Ultragenyx Pharmaceutical Inc, Cure Sanfilippo Foundation, Orchard Therapeutics, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sio Gene Therapies, Ara Parseghian Medical Research Fund, Dana's Angels Research Trust, Takeda, Travere Therapeutics, Inc., Noah's Hope - Hope4Bridget Foundation
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov