NCT07764822尚未招募不适用
Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with usable eye-tracking biomarker data
研究概览
简要总结
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 14 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Children born at <37 weeks' gestational age who are 14-48 months old at time of referral
- Ambulatory (i.e., cruising, walking)
- Without significant visual impairment
- Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R/F screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)
排除标准
- Non-English-speaking participants and families.
研究组 & 干预措施
Intervention
Experimental
Eye-tracking device
干预措施: Eye-tracking device (Device)
结局指标
主要结局
Number of participants with usable eye-tracking biomarker data
时间窗: Day 1
The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Number of participants with suspected autism
时间窗: Day 1
The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.
次要结局
- Caregiver attitudes towards use of the eye-tracking device(Day 1)
- Individual and Family Predictors (IFP)(Day 1)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07764822
- 其他研究编号
- 31847
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
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