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临床试验/NCT03894566
NCT03894566进行中(未招募)不适用

NASCITA (Nascere E Crescere in Italia): an Italian Birth Cohort Study

Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年4月1日最近更新:
适应症

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)

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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