NCT05171751已完成不适用
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood glucose
研究概览
简要总结
To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
详细描述
Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.
- •patients treated with octreotide subcutaneous injection.
排除标准
- •Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide
- •Secondary hypoglycemia caused by diseases other than CHI
- •Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.
- •Patients who intervene/interfere with octreotide treatment regimen for parental reasons
结局指标
主要结局
blood glucose
时间窗: 1 year
Maintain target blood glucose ≥3.3mmo/L
次要结局
未报告次要终点
研究者
Chunxiu Gong
director
Beijing Children's Hospital
研究点 (1)
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