NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants
Completed · Not applicable
Conditions studied: Rare Diseases
In brief
Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue to receive standard of care until Day 60. The standard of care group will receive cWGS and a clinical report at Day 60 as part of secondary and tertiary analyses. Both groups will be followed for a total of 90 days.
Key facts
- Study ID
- NCT03290469
- Run by
- Illumina, Inc.
- People needed
- 355
- Starts
- 2017-09-14
- Expected to finish
- 2020-01-13
- Last updated by the study team
- 2020-11-18
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Proband Exclusion Criteria
- Known non-genetic cause(s) of disease, disorder, or phenotypic defect
- The phenotype is fully explained by complications of prematurity
- Trisomy 13, 18 or 21 or Turner Syndrome is the likely diagnosis; such a proband will be eligible if a diagnostic karyotype is normal
- Blood transfusion within 48 hours (each proband will be re-eligible 48 hours after the most recent transfusion)
- The PI decides that the study is not in the best interest of the proband (for example, the neonate or infant is at a high risk of severe morbidity or mortality within the next 7 days and these risks could be mitigated by alternative testing). Subsequent eligibility for enrollment of each proband is at the discretion of the site PI.
Where it is running
- Rady's/Children's Hospital of Orange County — Orange, California, United States
- Washington University in St. Louis School of Medicine & St. Louis Children's Hospital — St Louis, Missouri, United States
- University of Nebraska Medical Center & Children's Hospital — Omaha, Nebraska, United States
- Children's Hospital of Philadelpia — Philadelphia, Pennsylvania, United States
- LeBonheur Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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