protocolSection identificationModule nctId: NCT06306521, orgStudyIdInfo id: 20235517, briefTitle: An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing, acronym: BeginNGS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rady Pediatric Genomics & Systems Medicine Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: BeginNGS Test, outcomesModule primaryOutcomes measure: Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention, secondaryOutcomes measure: Utility secondary outcome 1, secondaryOutcomes measure: Utility secondary outcome 2, secondaryOutcomes measure: Utility secondary outcome 3, secondaryOutcomes measure: Utility secondary outcome 4, secondaryOutcomes measure: Utility secondary outcome 5, secondaryOutcomes measure: Utility secondary outcome 6, secondaryOutcomes measure: Utility secondary outcome 7, secondaryOutcomes measure: Utility secondary outcome 8, secondaryOutcomes measure: Utility secondary outcome 9, secondaryOutcomes measure: Utility secondary outcome 10, secondaryOutcomes measure: Acceptability outcome 1, secondaryOutcomes measure: Acceptability outcome 2, secondaryOutcomes measure: Acceptability outcome 3, secondaryOutcomes measure: Acceptability outcome 4, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 1, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 2, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 3, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 4, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 5, secondaryOutcomes measure: Cost effectiveness outcome 1, secondaryOutcomes measure: Cost effectiveness outcome 2, secondaryOutcomes measure: Cost effectiveness outcome 3, secondaryOutcomes measure: Cost effectiveness outcome 4, secondaryOutcomes measure: Accuracy outcome 1, secondaryOutcomes measure: Accuracy outcome 2, secondaryOutcomes measure: Utility secondary outcome 11, secondaryOutcomes measure: Feasibility outcome 6, secondaryOutcomes measure: Feasibility outcome 7, secondaryOutcomes measure: Utility secondary outcome 12, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Rady Children's Hospital San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92123, country: United States, contacts name: Lauren Olsen, MSN, role: CONTACT, phone: 858-576-1700, phoneExt: 228456, email: lolsen1@rchsd.org, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False