NCT01578135已完成不适用
French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Growth in height
研究概览
简要总结
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born small for gestational age
排除标准
- 未提供
研究组 & 干预措施
Phase I
干预措施: somatropin (Drug)
Phase II
干预措施: somatropin (Drug)
结局指标
主要结局
Growth in height
时间窗: 6 months after inclusion into registry and then annually until adult height is reached
次要结局
- Insulin-Like Growth Factor 1 (IGF-1)(6 months after inclusion into registry and then annually until adult height is reached)
- Blood pressure: Systolic and diastolic(6 months after inclusion into registry and then annually until adult height is reached)
- Bone age(6 months after inclusion into registry and then annually until adult height is reached)
研究者
研究点 (1)
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