NCT01314989Unknown4 期
Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 to 4 years of age
- •failure to thrive
排除标准
- •Medication affecting appetite
- •Medication interacting with Cyproheptadine
- •Prematurity under 36 weeks of gestation
- •Neurologic impairment
- •underlying organic disease
研究组 & 干预措施
Sugar pill
Placebo Comparator
Cross-over study
干预措施: Sugar pill (Drug)
Cyproheptadine
Active Comparator
Cross-over study
干预措施: Cyproheptadine (Drug)
结局指标
主要结局
Weight gain
时间窗: January 2011 to January 2012
次要结局
- Feeding behaviour(January 2011 to January 2012)
研究者
研究点 (1)
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