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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
NCT03290469 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER clinical whole genome sequencing (cWGS)
Study Locations (5)
California
- Rady's/Children's Hospital of Orange County — Orange
Missouri
- Washington University in St. Louis School of Medicine & St. Louis Children's Hospital — St Louis
Nebraska
- University of Nebraska Medical Center & Children's Hospital — Omaha
Pennsylvania
- Children's Hospital of Philadelpia — Philadelphia
Tennessee
- LeBonheur Hospital — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2020-01-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03290469
The ClinicalTrials.gov registry entry for NCT03290469 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 355 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Illumina, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rare Diseases appearing as the primary indexed condition, and to 1 intervention — of which clinical whole genome sequencing (cWGS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03290469 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Missouri, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03290469 about?
NCT03290469 is a clinical study titled "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". 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 wil...
What is the current status of trial NCT03290469?
This trial is currently completed. It is a NA study. The enrollment target is 355 participants. The study started on 2017-09-14. Estimated completion is 2020-01-13.
What conditions does trial NCT03290469 study?
This clinical trial studies the following conditions: Rare Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03290469?
The interventions under investigation include: clinical whole genome sequencing (cWGS) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03290469?
This trial is sponsored by Illumina, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03290469 being conducted?
This trial has 5 study locations across California, Missouri, Nebraska, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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