Status:
COMPLETED
Genomic Sequencing in Acutely Ill Neonates
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Diseases/Diagnoses
Genetic Disease
Eligibility:
All Genders
Up to 4 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effectiveness of rapid next generation sequencing (NGS, such as whole genome sequencing1) with current practice to provide diagnostic or prognostic informat...
Detailed Description
This is a randomized, blinded, prospective study examining the comparative effectiveness - both clinical and cost effectiveness - of rapid NGS (StatSeq), compared to standard of care, including an exp...
Eligibility Criteria
Inclusion
- One of the following criteria required.
- Clinical genetic testing or a genetic consult is ordered
- Subject has one major structural anomaly or three or more minor anomalies
- Abnormal laboratory testing suggestive of a genetic disease
- Abnormal response to standard therapy for a major underlying condition
Exclusion
- Previously confirmed genetic diagnosis that explains the clinical condition
- Has features pathognomonic for a large chromosomal aberration (Trisomy 13, 18, 21 or other)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02225522
Start Date
October 1 2014
End Date
September 1 2016
Last Update
June 23 2017
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108