Children Born Preterm: Sustainable Health Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- Childhood development
研究概览
简要总结
Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.
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
- 20 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
- •Acquisition of the informed consent
排除标准
- •Residing outside Tuscany region
结局指标
主要结局
Childhood development
时间窗: The measurements will be assessed at 56-66 months of age
Childhood development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Childhood development is assessed with the Ages and Stages Questionnaires (ASQ-3).
Infant development
时间窗: The measurements will be assessed at 20-28 months of age
Infant development comprises physical, cognitive, social-emotional, linguistic, and behavioral milestones. Infant development is assessed with the Bayley Scales Of Infant and Toddler Development third edition (Bayley - III).
次要结局
- Presence of asthma(The measurements will be assessed at 56-66 months of age)
- Presence of visual or hearing impairement(The measurements will be assessed at 20-28 months of age and at 56-66 months of age)
- Access to care(The measurements will be assessed at 20-28 months of age and at 56-66 months of age)
研究者
Vieri Lastrucci
MD
Meyer Children's Hospital IRCCS