Actively Recruiting
An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
Led by Rady Pediatric Genomics & Systems Medicine Institute · Updated on 2024-03-12
10000
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates less than 28 days old at enrollment sites
- Parents must have identified a primary care provider or group
You will not qualify if you...
- Neonates whose mother is less than 18 years old
- Neonates who are wards of the state
- Neonates whose parent or legal guardian is unable to provide consent
- Parents with a home address outside the US or enrollment site jurisdictions
- Neonates or fetuses who are ill where enrollment or sampling may interfere with healthcare at delivery, such as likely transfer to a Level IV NICU
- Neonates under consideration for rapid diagnostic genome sequencing or other genetic testing
- Neonates not expected to survive the neonatal period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Actively Recruiting
Research Team
L
Lauren Olsen, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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