Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

Albert Einstein College of Medicine

Collaborating Sponsors:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Alexion Pharmaceuticals, Inc.

Conditions:

Acid Sphingomyelinase Deficiency

Ceroid Lipofuscinosis, Neuronal, 2

Eligibility:

All Genders

Up to 4 years

Brief 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 n...

Detailed Description

Soon after birth, all babies born in the United States have a newborn screening (NBS) test to check for certain medical conditions. All babies are screened, even if they appear healthy, because most o...

Eligibility Criteria

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

Key Trial Info

Start Date :

May 10 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 31 2029

Estimated Enrollment :

100000 Patients enrolled

Trial Details

Trial ID

NCT05368038

Start Date

May 10 2021

End Date

August 31 2029

Last Update

September 12 2025

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Maimonides Medical Center

Brooklyn, New York, United States, 11219

2

NYU Langone Hospital - Brooklyn

Brooklyn, New York, United States, 11220

3

North Shore University Hospital

Manhasset, New York, United States, 11030

4

NYU Langone Health - Tisch Hospital

New York, New York, United States, 10016