NCT00557336已完成3 期
Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 38
- 主要终点
- Height gain according to birth group, age of onset, the treatment and Tanner stage
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
- •Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
- •Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
- •Normal response to GH stimulation test (greater than 10 ng/mL)
排除标准
- •Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
- •Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
- •History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
- •Previous or ongoing growth hormone therapy
结局指标
主要结局
Height gain according to birth group, age of onset, the treatment and Tanner stage
时间窗: during 12 months of treatment
次要结局
- Height SDS for bone age(during 12 months of treatment)
- Height velocity SDS for bone age(during 12 months of treatment)
- Height velocity for chronological age(during 12 months of treatment)
研究者
研究点 (38)
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