NCT06821386招募中不适用
N-Care Project: Enhancing Asian-Pacific Collaboration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Positive yield rate
研究概览
简要总结
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.
详细描述
A group of individuals with specific characteristics was selected. Genetic studies were arranged for participants who provided their consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: infant/newborn less than 18 months
- •Admitted to intensive care unit
- •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
排除标准
- •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
- •Confirmed genetic diagnosis explains illness
- •Lack of consent: Families who do not consent to genetic testing or data sharing.
- •Infants without sufficient DNA sample quality/quantity: Where the quality or quantity of the DNA sample is inadequate for sequencing.
结局指标
主要结局
Positive yield rate
时间窗: 9 days after enrollment
The percentage of individuals who test positive among the long-read sequencing exam
次要结局
未报告次要终点
研究者
研究点 (1)
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