Status:

RECRUITING

Genomic Uniformed-Screening Against Rare Disease In All Newborns

Lead Sponsor:

Columbia University

Collaborating Sponsors:

Illumina, Inc.

GeneDx

Conditions:

Early Onset Genetic Conditions With Near Complete Penetrance

Eligibility:

All Genders

1-1 years

Phase:

NA

Brief Summary

The goal of this study is to learn how genomic sequencing technology can be used to effectively expand the conditions screened on newborn screening. Newborn screening ensures equity and allows all bab...

Detailed Description

Newborn screening (NBS) is the process of screening all newborns for select conditions shortly after birth. This process reduces morbidity and mortality by the detection of medically actionable condit...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Newborns admitted to the well-baby nurseries from the recruiting hospitals
  • Newborns born after 33 weeks of gestation
  • Newborns whose parents are English, Mandarin, or Spanish speaking

Exclusion

    Key Trial Info

    Start Date :

    September 6 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2029

    Estimated Enrollment :

    100000 Patients enrolled

    Trial Details

    Trial ID

    NCT05990179

    Start Date

    September 6 2022

    End Date

    September 1 2029

    Last Update

    September 19 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Columbia University Irving Medical Center/NYP

    New York, New York, United States, 10032