Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
研究概览
简要总结
In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with congenital hypothyroidism
- •Eutopic thyroid gland or thyroid hemiagenesis
- •Born between 1996 and 2017
- •Treated at the Nancy Regional and University Hospital
- •Follow-up of at least 3,5 years.
排除标准
- •Polymalformative syndrome
- •Thyroid dysgenesis except for thyroid hemiagenesis
结局指标
主要结局
Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
时间窗: 42 months
次要结局
- Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.(42 months)
- Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).(42 months)
- Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up.(6 months, 1 year, 2 years, 3 years)
研究者
RENARD Emeline
MD
Central Hospital, Nancy, France