CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Well infant, whole exome sequencing +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02826694
NCT02826694N/ACompleted
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North Carolina Newborn Exome Sequencing for Universal Screening

University of North Carolina, Chapel Hill·interventional·Posted Jul 11, 2016·Updated Jul 8, 2020

In Brief

A clinical study evaluating Well infant, whole exome sequencing and Diagnosed, whole exome sequencing for Metabolism, Inborn Errors and 2 related conditions. Completed, enrolled 106 participants across 1 site.

Detailed Summary

The NC NEXUS research study is exploring the utility of next generation sequencing in newborn screening and parental decision making. The National Institutes of Health (NICHD and NHGRI) are co-funding this study under a single U-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism, Inborn Errors, Hearing Loss, Hereditary Disease
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Human Genome Research Institute (NHGRI), RTI International

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 11, 2016
Enrollment StartJun 1, 2016
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.0 years ago

Interventions

Well infant, whole exome sequencinggenetic

Whole exome sequencing will be performed in children with diagnosed conditions. Investigators will analyze results that are associated with their condition.

Diagnosed, whole exome sequencinggenetic

In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable.