Genomic Uniformed-Screening Against Rare Disease In All Newborns
Columbia University · with Illumina, Inc., GeneDx · NCT05990179
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
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