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N/A Completed N=106 Randomized Diagnostic

North Carolina Newborn Exome Sequencing for Universal Screening

Metabolism, Inborn Errors · Hearing Loss · Hereditary Disease
Source: ClinicalTrials.gov NCT02826694 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Parental Choices Following Decision Aid — 120; 57; 25; 2 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Parental Choices Following Decision Aid
120; 57; 25; 2
PRIMARY
Number of Participants Identified With Genetic Conditions Through Whole Exome Sequencing
61; 0; 0; 28; 0; 17
SECONDARY
Parental Reaction Scores
2.3; 1.7; 2.5; 1.5 0.168

Eligibility Criteria

Inclusion Criteria

  • Uncomplicated pregnancy and healthy newborn

Exclusion Criteria

  • Abnormalities such as major malformation or chromosomal disorder detected prenatally or significant complications during pregnancy or at the time of delivery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02826694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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