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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2020-11-18

No results posted yet for this 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

Interventions

OTHER

clinical whole genome sequencing (cWGS)

Clinical Whole Genome Sequencing (cWGS) consists of the sequencing, analysis and interpretation of subjects samples and a return of the result to the ordering physician.

Sponsors & Collaborators

  • Le Bonheur Children's Hospital

    collaborator OTHER

  • Rady Pediatric Genomics & Systems Medicine Institute

    collaborator OTHER

  • Children's Hospital of Orange County

    collaborator OTHER

  • Children's Hospital and Medical Center, Omaha, Nebraska

    collaborator OTHER

  • St. Louis Children's Hospital

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Illumina, Inc.

    lead INDUSTRY

Principal Investigators

  • Ryan J. Taft, PhD · Illumina, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
120 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2019-04-30
Completion
2020-01-13

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290469 on ClinicalTrials.gov