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Genomic Uniformed-Screening Against Rare Disease In All Newborns

Columbia University · with Illumina, Inc., GeneDx · NCT05990179

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–1 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
100000
US sites recruiting
1
Study start
September 6, 2022
Record last updated
September 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 babies to have the same chance at the healthiest life. Families will be invited to have their newborn baby screened for additional conditions beyond what all babies are screened for as part of the newborn screening public health program. Families can choose to be part of the study or choose not to be part of the study and just have the routine newborn screening test. Families will also be able to choose to learn about their baby's risk for conditions that have effective treatments available but are not on the routine newborn screening panel or also learn about conditions for which there is not currently FDA approved medications but for which medications are under development or for which early intervention services or treatment of seizures may improve the child's outcome. Families will be invited to the study shortly after the baby is born and will learn the decision not to participate, and we will interview a subset of parents who agree to be interviewed. Newborns who screen positive will be referred to appropriate providers for care and will be followed through review of electronic medical records and parental follow up via phone, text, postal mail or email.

Being studied: Genome sequencing-based newborn screening

Conditions: Early Onset Genetic Conditions With Near Complete Penetrance

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Columbia University Irving Medical Center/NYP

    New York, NY 10032

    Site contact: Anah Hetzler · 212-305-5508 · ak3578@cumc.columbia.edu

Study contacts (from the official record)

  • Anah Hetzler · 212-305-5508 · ak3578@cumc.columbia.edu
Genomic Uniformed-Screening Against Rare Disease In All Newborns (NCT05990179) | Bored Studies