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Recruiting NCT06821386

N-Care Project: Enhancing Asian-Pacific Collaboration

Trial Parameters

Condition Whole Genome Sequencing
Sponsor National Taiwan University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age N/A
Max Age 18 Months
Start Date 2025-02-17
Completion 2025-12-31
Interventions
Genetic study with nanopore sequencing

Brief Summary

Through Asian-Pacific multinational collaboration, we aim to utilize third-generation genome sequencing to rapidly diagnose genetic diseases in critically ill infants and young children, achieving the goal of early diagnosis for targeted treatment.

Eligibility Criteria

Inclusion Criteria: 1. Age: infant/newborn less than 18 months 2. Admitted to intensive care unit 3. At least one of the following conditions A. Specific anomaly highly suggestive of a genetic etiology * Multiple birth defects * Single major malformation that required intervention (surgery or medication) * Significantly abnormal EKG * Significant hypotonia B. Children with high-risk stratification on assessment of a Brief Resolved Unexplained Event (BRUE) with any of the following: * Recurrent severe infection events * Recurrent or prolonged seizures * Unexplained cardiopulmonary resuscitation (CPR) * Suspect inborn error of metabolism Exclusion Criteria: 1. Infants with a definitive non-genetic diagnosis: ex as below A. An infection with normal response to therapy B. Isolated prematurity C. Transient hypoglycemia D. Isolated unconjugated hyperbilirubinemia E. Isolated Transient Neonatal Tachypnea F. Those where the clinical course can be explained without genetic testing 2. Confirmed

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