Rapid Diagnostics for Genetic Disorders in Neonates

Part of paid clinical trials in San Diego, California.

Sponsor
Sharp HealthCare
Study ID
NCT07005700
Status
Not Yet Recruiting

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Conditions

  • Acid Base Disorder

Eligibility Criteria

Sex
ALL
Age
1 Day - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Targeted genomic sequencing — DIAGNOSTIC_TEST
    Single 0.5 mL venous or capillary blood sample.

Study Details

The goal of this study is to test a prototype genomic blood analysis for identifying rare diseases in infants hospitalized in the neonatal intensive care unit (NICU). The main question it aims to answer is: Does the prototype accurately identify genetic variation(s) associated with an infant's health condition? Researchers will compare the prototype's gene identification to traditional genome sequencing methods of gene identification. Participants will be asked to provide a very small (one-tenth of a teaspoon) sample of blood, one-time.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Consented, Enrolled
    All participants who meet inclusion and exclusion criteria and whose parent has provided written informed consent.

Primary Outcome Measure

Identification of genes associated with congenital diseases [ Time Frame: birth through hospital discharge or up to 1 month of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sharp Mary Birch Hospital for Women and NewbornsSan DiegoCalifornia92123
Jason B Sauberan, PharmD
[email protected]
858-939-7424

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By research site
Sharp Mary Birch Hospital for Women and Newborns· San Diego, CA