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Rapid Diagnostics for Genetic Disorders in Neonates
Sponsor: Sharp HealthCare
Summary
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.
Official title: Development of Rapid Diagnostics for Genetic Disorders in Neonates Using a Novel Targeted Genomic DNA Sequencing Analysis Panel.
Key Details
Gender
All
Age Range
1 Day - 6 Months
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-06-30
Completion Date
2027-05
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
Targeted genomic sequencing
Single 0.5 mL venous or capillary blood sample.
Locations (1)
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States