Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose Adjustments
研究概览
简要总结
This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns diagnosed with congenital hypothyroidism (CH).
- •Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location.
- •Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis.
排除标准
- •Newborns who do not have CH.
- •Newborns with CH who have not had thyroid imaging performed at diagnosis.
研究组 & 干预措施
Targeted dosing
Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
干预措施: Levothyroxine (Drug)
Targeted dosing
Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
干预措施: Ultrasound (Device)
结局指标
主要结局
Dose Adjustments
时间窗: 6 months
Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.
次要结局
- Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls(6 months)
研究者
Erica Eugster
Pediatric Endocrinologist
Indiana University