Growth Hormone Trial for Children With 18q- and Abnormal Growth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- growth rates 12-15 months after treatment begins
研究概览
简要总结
We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
详细描述
HYPOTHESIS:
Our hypothesis with reference to children with 18q deletions who have abnormal growth are:
- growth hormone will improve growth; and
- growth hormone will improve performance IQ (pIQ).
Therefore, our specific aims are to evaluate the impact of GH treatment on:
- linear growth in children with 18q deletions who have abnormal growth but who are not classically growth hormone deficient; and
- pIQ in children with 18q deletions who have abnormal growth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of chromosome 18 deletion (cytogenetics report)
- •Children with abnormal growth but who are not classically growth hormone deficient
排除标准
- •Children previously on growth hormone therapy
研究组 & 干预措施
Growth Hormone Treatment
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done 1st for eligibility and this group received GH (growth hormone) (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)immediately after randomization
干预措施: Nutropin AQ (Drug)
Growth Hormone Treatment
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done 1st for eligibility and this group received GH (growth hormone) (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)immediately after randomization
干预措施: Arginine and Clonidine Stimulation Testing (Procedure)
Growth Hormone Treatment
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done 1st for eligibility and this group received GH (growth hormone) (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)immediately after randomization
干预措施: Growth Factors Laboratory Testing (Procedure)
Growth Hormone Treatment
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done 1st for eligibility and this group received GH (growth hormone) (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)immediately after randomization
干预措施: Neuropsychological Testing (Procedure)
GH treatment delayed by one year
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done first for eligibility and this group received growth hormone (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)after one year of observation
干预措施: Arginine and Clonidine Stimulation Testing (Procedure)
GH treatment delayed by one year
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done first for eligibility and this group received growth hormone (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)after one year of observation
干预措施: Growth Factors Laboratory Testing (Procedure)
GH treatment delayed by one year
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done first for eligibility and this group received growth hormone (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)after one year of observation
干预措施: Neuropsychological Testing (Procedure)
结局指标
主要结局
growth rates 12-15 months after treatment begins
次要结局
- performance IQ scores 12-15 months after treatment begins