ACTRN12617000441314招募中4 期
A Course of Oxytocin to Improve Social Communication in Young Children with Autism
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Years 至 12 Years（—）
- 性别
- All
入选标准
- •Participants must meet DSM-5 criteria for Autism Spectrum Disorder (ASD)..
排除标准
- •Participants will be excluded if they are known to be hypersensitive to the preservatives in the nasal spray (E216, E218, and chlorobutanol hemihydrates). Participants with severe nasal obstruction/blockage will be excluded as this is likely to reduce the efficacy of the nasal spray medication. Further, participants whose caregivers report that they have a serious medical condition from one of the following categories will be excluded (evidenced through medical examination):
- •1. severely compromised cardiac function
- •2. severely compromised hepatic function
- •3. severely compromised renal function
- •These categories relate to common side-effects reported in previous oxytocin studies and recommended contraindications from product information for the nasal spray and intravenous formulations of oxytocin that have been marketed previously.
研究者
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