Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,404
- 试验地点
- 190
- 主要终点
- Health disorders assessed by medical exam
研究概览
简要总结
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).
These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.
At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.
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
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •initially included in EPIPAGE 2 cohort or complementary studies or Elfe cohort study
- •family agreement to participate to cohort follow up
- •informed consent form signed by both parents
- •affiliated to social security system
排除标准
- •parental refusal
- •not affiliated to any social security system
结局指标
主要结局
Health disorders assessed by medical exam
时间窗: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Motor disorders assessed by medical exam
时间窗: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Cognitive disorders assessed by psychological testing
时间窗: 5 years 5 months- 5 years 11 months
According to gestational age at birth
Behavioural disorders by psychological testing
时间窗: 5 years 5 months- 5 years 11 months
According to gestational age at birth
次要结局
- Changes in medical practices collected by questionnaire(5 years 5 months- 5 years 11 months)
- Set up a DNA Biobank by saliva samples collection(5 years 5 months- 5 years 11 months)
- Changes in organization of care collected by questionnaire(5 years 5 months- 5 years 11 months)