Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 252
- 试验地点
- 22
- 主要终点
- Scores of global development Quotient (WISC-R)
研究概览
简要总结
- MAIN OBJECTIVE :
To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years 2. SECONDARY OBJECTIVES :
- To assess the consequences of a maternal hyperthyroïd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.
- To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:
- the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid versus disease of Basedow),
- the use or not of a anti-thyroid treatment,
- the rate of TSH néonatal (measured with the blotter by tracking with J3 at all the new born ones).
详细描述
- INCLUSION CRITERIA :
- Old from 6 to 9 years included
- Age of gestation between ≥37 and <41 weeks of amenorrhoea
- Born from a mono-foetale pregnancy
- Euthyroïd at the time of the entry in the study
- Provided education for at the elementary school on a level adapted to its age
- NON INCLUSION CRITERIA :
- Presenting a congenital hypothyroïd or a known thyroid dysfonction at the time of the entry in the study
- Carrier of a chronic pathology (organic or psychological) or malformative severe
- Presenting an antecedent of Deficit of the Attention-Hyperactivity to the 1st degree
- EXCLUSION CRITERIA :
o Discovered of a thyroid dysfonction at the time of the entry in the study 4. STRATEGIES / PROCEDURES :
Multicentric, comparative study of a troop of child born to hyperthyroïd mothers during pregnancy (children exposed to the maternal hyperthyroïd) and children born to euthyroïd mothers during pregnancy (nonexposed children with the maternal hyperthyroïd).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •A-For the child born to hyperthyroid mother during pregnancy :
- •oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age
- •B-For hyperthyroid mother during pregnancy :
- •oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyroïd at the time of the entry in the study
- •C-For the child born to euthyroid mother during pregnancy :
- •oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age
- •D-For euthyroid mother during pregnancy :
- •Euthyroïd at the time of the entry in the study
排除标准
- •A-For the child born to hyperthyroid mother during pregnancy :
- •Discovered of a thyroid dysfonction at the time of the entry in the study
- •B-For hyperthyroid mother during pregnancy:
- •Discovered of a thyroid dysfonction at the time of the entry in the study
- •C-For the child born to euthyroid mother during pregnancy:
- •Discovered of a thyroid dysfonction at the time of the entry in the study
- •D-For euthyroid mother during pregnancy:
- •oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study
研究组 & 干预措施
child born to hyperthyroid mother during pregnancy
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
干预措施: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. (Behavioral)
child born to euthyroid mother during pregnancy
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
干预措施: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. (Behavioral)
结局指标
主要结局
Scores of global development Quotient (WISC-R)
时间窗: within the first 30 days after inclusion of the patient
次要结局
- Score of the Achenbach Child Behavior Checklist(within the first 30 days after inclusion of the patient)
- Score of the conners scale(within the first 30 days after inclusion of the patient)
- Score of the Wechsler Intelligence Scale for Children (WISC-IV)(within the first 30 days after inclusion of the patient)