Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 主要终点
- NEUROLOGICAL EXAMINATION; Child Behavior Check List
研究概览
简要总结
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".
详细描述
The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
排除标准
- 未提供
结局指标
主要结局
NEUROLOGICAL EXAMINATION; Child Behavior Check List
时间窗: 10 years
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients
次要结局
未报告次要终点