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An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
Sponsor: Rady Pediatric Genomics & Systems Medicine Institute
Summary
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 acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening? Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test.
Key Details
Gender
All
Age Range
1 Day - 28 Days
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2024-02-29
Completion Date
2029-02
Last Updated
2024-03-12
Healthy Volunteers
Yes
Conditions
Interventions
BeginNGS Test
Genomic sequencing that screens for over 400 genetic diseases.
Locations (1)
Rady Children's Hospital San Diego
San Diego, California, United States