NL-OMON44462已完成2 期
Randomized, double-blind, placebo-controlled oxytocin trial in children with Prader-Willi syndrome. Effects on social behaviour. - RCT intranasal administration oxytocin in children with PWS
Stichting Kind en Groei0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- Genetically confirmed diagnosis of Prader-Willi syndrome
- •- Children aged 3 to 10.99 years
- •- Informed consent
- •- Currently on growth hormone treatment for at least 1 year
- •- Behavioural characteristics such as reduced social reciprocity and interaction, repetitive behaviour or temper tantrums, and/or be in nutritional phase 2b or 3 according to Miller (increased interest in food, hyperphagia)
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Severe psychiatric problems
- •- Non-cooperative behaviour
- •- Allergic reactions or hypersensitivity for oxytocin
- •- Serious illness
- •- Cardiac abnormalities
- •- Extremely low dietary intake or less than required intake according to WHO
- •- Medication to reduce weight (fat)
研究者
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