NCT00565890已完成不适用
Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Psychomotor development at 1.5 years of age
研究概览
简要总结
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
详细描述
A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight: less than 1500g
- •Gestation: 22 weeks 0 day ≤
- •Serum free thyroxine level lower than 0.8 ng/dl
- •Serum thyrotropin lower than 10 μU/ml
- •Age of between 2 and 4 weeks after birth
- •Informed consent
排除标准
- •any known thyroid disease in mother
研究组 & 干预措施
2
No Intervention
No replacement therapy
干预措施: thyroxine (Drug)
结局指标
主要结局
Psychomotor development at 1.5 years of age
时间窗: 18 months
次要结局
- Psychomotor development at 3 years of age(6 years)
- Somatic growth at 3 years of age(6 years)
- Duration of hospital stay(6 years)
- Frequency of morbidities during the stay in NICu(6 years)
研究者
Satoshi Kusuda
Director
Tokyo Women's Medical University
研究点 (1)
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