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An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing

Rady Pediatric Genomics & Systems Medicine Institute · NCT06306521

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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
10000
US sites recruiting
1
Study start
February 29, 2024
Record last updated
March 12, 2024

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

What the study 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.

Being studied: BeginNGS Test

Conditions: Genetic Disease

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Neonates (\<28 days old) at enrollment sites.
  • Parents must have identified a primary care provider (or group).

Exclusion Criteria

  • Neonates whose mother is less than 18 years of age.
  • Neonates who are wards of the state.
  • Neonates whose parent/legal guardian is unable to provide consent.
  • Parents with a home address outside the US or jurisdiction of the enrollment sites.
  • Neonates or fetuses who are ill and in whom enrollment or sampling is anticipated to interfere with healthcare provision at delivery. For example, fetuses or neonates who are likely to require transfer to a higher level of care, such as to a Level IV NICU upon delivery.
  • Neonates who are under consideration for a rapid diagnostic genome sequence or other diagnostic genetic testing.
  • Neonates who are not expected to survive the neonatal period.

Recruiting US locations

  • Rady Children's Hospital San Diego

    San Diego, CA 92123

    Site contact: Lauren Olsen, MSN · 858-576-1700 · lolsen1@rchsd.org

Study contacts (from the official record)

  • Lauren Olsen, MSN · 858-576-1700 · lolsen1@rchsd.org
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An Adaptive Clinical Trial of BeginNGS Newborn Screening for… (NCT06306521) | Bored Studies