EUCTR2010-021134-66-FR进行中（未招募）1 期
Efficacy assessment of systematic treatment with folinic acid and thyroid hormone on psychomotor development of Down Syndrome young children - ACTHYF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patient with a caryotype of a homogenous trisomy 21, free or with or robertsonian translocation,
- •-Patient with echocardiography showing no evidence of cardiopathy or valular leak,
- •-Patient aged 6 to 18 months at inclusion,
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 256
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-patient with current or past hypothyroidy
- •-patient with current or past TSH> 5mUI/l,
- •-leucémoid reaction at birth
- •-past or present leukemia, West Syndrome, seizure or any other neurological instable disorder,
- •-past or present signs of CNS damage : stroke, hypoxia, meningitis,
- •-past or present severe cardiac disease or significant valvular leak at echocardiography,
- •- uncontrolled cardiac rythm abnormalities,
- •-Apgar < 7 at 5 mn of birth,
- •- gestationnal age < 245 jours (35 semaines),
研究者
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