Optimizing Initial Levothyroxine Dosing in Neonates With Congenital Hypothyroidism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Normalization of thyroid function after two weeks of treatment
研究概览
简要总结
This randomized controlled trial compared high-dose and moderate-dose levothyroxine as initial therapy for neonates with primary congenital hypothyroidism. One hundred one infants were randomized to receive either approximately 12.85 or 7.65 µg/kg/day. Thyroid function and dose adjustments were assessed every 2 weeks over the first six weeks of treatment to evaluate efficacy and safety.
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
- None
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates diagnosed with primary congenital hypothyroidism.
- •Full-term infants.
- •Newly diagnosed.
- •Treatment initiated during the neonatal period.
- •Written informed parental consent.
排除标准
- •Central congenital hypothyroidism.
- •Prematurity.
- •Major congenital malformations.
- •Serious systemic illness affecting thyroid function.
- •Previously thyroid hormone therapy.
研究组 & 干预措施
High-dose Levothyroxine Group
Participants received initial levothyroxine therapy at a mean dose of 12.85 ± 1.12 µg/kg/day
干预措施: Levothyroxine (Drug)
Moderate-dose Levothyroxine Group
Participants received initial levothyroxine therapy at a mean dose of 7.65 ± 0.56 µg/kg/day.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
Normalization of thyroid function after two weeks of treatment
时间窗: Two weeks
Comparison of serum TSH and free T4 between treatment groups after two weeks of levothyroxine therapy.
次要结局
未报告次要终点
研究者
Amira Fathy El-Fiky
Lecturer of pediatrics
Menoufia University