Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age
研究概览
简要总结
Currently in France, screening for congenital hypothyroidism (CH) in premature infants is done by a single TSH assay on filter paper. However, European recommendations advise repeating the assay within the first month of life.
Our primary objective is to estimate the incidence of CH in preterm infants under 32 weeks of gestational age by applying the European recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days), both female and male, of all ethnic origins, regardless of birth weight, and including all other pathologies.
- •Newborns whose parents have given their non-opposition consent.
排除标准
- •Newborns born who leave the region before day
- •Newborns who die before 15 days of age.
- •Newborns whose parents are not affiliated with the social security system.
研究组 & 干预措施
Premature newborn
Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days)
干预措施: Blood test (Biological)
结局指标
主要结局
Annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age
时间窗: From birth to Day 15 of life
The primary objective of the study is to estimate the annual incidence of congenital hypothyroidism among premature infants born before 32 weeks of gestational age, within 15 days of birth, by applying the European recommendations, which consist of performing two repeated tests within the first 15 days.
次要结局
- Rate of patient negative to congenital hypothyroidism (CH) test(Day 3)
- Rate of patient positive to congenital hypothyroidism (CH) test(Day 15)
- persistency of congenital hypothyroidism (CH)(2 years of age)
- Association between the risk factors mentioned in the literature (predefined factors) and the presence of congenital hypothyroidism in this population of premature infants(15 days at the time of the second sample)
- Effectiveness of the treatment(at 2 years of age)