NASCITA (Nascere E Crescere in Italia): an Italian Birth Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of respiratory tract infection episodes in the preschool period
研究概览
简要总结
The NASCITA study (NAscere e creSCere in ITAlia) was created to improve the understanding of the health status of Italian children early on and how it is affected by social and health determinants.
The study will evaluate physical, cognitive, and psychological development, and health status and health resource use during the first six years of life in a group of newborns, as well as potential associated factors. The association between the well-being of children and parental adherence to the recommendations for better child care and development will also be assessed.
Information on the children will be collected by paediatricians mostly during routine visits.
The findings will be used in the development of specific prevention measures and interventions to improve the health of children, in particular more vulnerable ones.
详细描述
The NASCITA study (NAscere e creSCere in ITAlia) was created to improve the understanding of the health status of Italian children early on and how it is affected by social and health determinants. The findings will be used in the development of specific prevention measures and interventions to improve the health of children, in particular more vulnerable ones.
The hypotheses are that:
- differences due to environmental, sociodemographic, and parental determinants, as well as to child characteristics and physician attitudes, exist between geographic areas in a population's health and in the use of health resources in the first few years of life;
- differences exist in the appropriateness of care provided by the National Health Service at different levels (regional, local, family pediatrician);
- differences exist between geographical settings in parental attitudes toward the recommendations concerning children's health care, and these differences may be a determinant of child development and well-being and health resource utilization;
- the existing differences between geographical settings in the opportunities for children to access educational/socialization experiences (e.g. day-care centers) may have an impact on development.
Aims:
- The main aim of the NASCITA cohort is to evaluate physical, cognitive, and psychological development, and health status and health resource use during the first six years of life in a group of newborns, and to evaluate potential associated factors.
- To evaluate differences between geographical settings in educational and socialization opportunities available for young children and in the care provided by the family pediatricians and by the National Health Service for the same needs
- To evaluate the association between the well-being of children and parental adherence to the recommendations for better child care and development.
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
- — 至 45 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Family pediatricians who can guarantee seven years of professional activity
- •Newborns seen by their family pediatrician for the first routine well-child visit within the first 45 days of life
排除标准
- •Children not born in Italy
结局指标
主要结局
Number of respiratory tract infection episodes in the preschool period
时间窗: At 6 years of life
Number of respiratory tract infection episodes
Height
时间窗: at 6 years of age
Height in meters
Child development
时间窗: At 6 years of life
Measured with the International Guide for Monitoring Child Development (GMCD), which involves 7 domains (language, fine and gross motor, relation, play and self-help) over 12 age periods from the 1st to the 42nd months. Each domain has specific age intervals that are met by typically developing children. If any of these are not met, a possible delay is noted. E.g. Fine motor (fine movements). "How does she use her hands and fingers, like holding objects?" \[9-11 months\]: Picks up small objects (like pieces of food using pincer (thumb and index finger) aided by other fingers. \[12-14 months\]: Picks up small objects using pincer (thumb and index finder) only.
Incidence of child overweight and obesity
时间窗: At 6 years of life
Measured as BMI in kg/m\^2
Number of children with asthma
时间窗: At 6 years of life
Number of children who have asthma
Childhood vaccinations
时间窗: At 6 years of life
The paediatrician will note which vaccines the child has received so far
Number of children with wheezing episodes
时间窗: At 3 years of life
Number of children who have had at least one wheezing episode
Number of hospitalizations
时间窗: At 6 years of life
The paediatrician will ask the mother about the number of hospitalizations
Weight
时间窗: At 6 years of life
Weight in kilograms
Duration of exclusive breastfeeding
时间窗: At 6 months of life
The paediatrician will ask the mother if she is still exclusively breastfeeding
Maternal vaccinations in pregnancy
时间窗: Within 45 days of life of the child
The paediatrician will ask the mothers which vaccines they received during the pregnancy
次要结局
- Hearing test(At 6 months of life)
