An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
Recruiting
N/A
Interventional Study
Genetic Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 Day – 28 Days
- Sex
- Any
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 10,000 (estimated)
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute · Other
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About This Trial
The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:
What is the utility of BeginNGS as compared to state newborn screening? What is the acceptabil…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Neonates (\<28 days old) at enrollment sites.
2. Parents must have identified a primary care provider (or group).
Exclusion Criteria:
1. Neonates whose mother is less than 18 years of age.
2. Neonates who are wards of the state.
3. Neonates whose parent/legal guardian is un…
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