Genomic Medicine for Ill Neonates and Infants (The GEMINI Study)

Summary

The Genomic Medicine for Ill Neonates and Infants (The GEMINI Study) is a research study aimed at comparing the clinical and economic utility of performing rapid whole genomic sequencing versus a targeted genomic sequencing panel on neonates and infants suspected of having a genetic disorder. This study is funded by the National Institutes of Health.

This multicenter, prospective clinical trial will enroll 400 subjects at the Floating Hospital for Children at Tufts Medical Center (Boston, MA), Cincinnati Children's Hospital Medical Center (Cincinnati, OH), Mount Sinai Kravis Children's Hospital (New York, NY), North Carolina Children's Hospital (Chapel Hill, NC), Children's Hospital of Pittsburgh (Pittsburgh, PA), and Rady Children's Hospital (San Diego, CA).

Conditions

• Pediatric: Genetic Syndrome

Interventions

DIAGNOSTIC_TEST

rapid whole genomic sequencing (rWGS)

rWGS and NewbornDx are genomic sequencing platforms

Sponsors & Collaborators

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Jill L Maron, MD, MPH · Women and Infants Hospital of Rhode Island

• Jonathan M Davis, MD · Tufts Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-24

Primary Completion

2021-11-01

Completion

2022-11-01

FDA Device

Yes

Countries

• United States

Study Locations