NASCITA Italian Birth Cohort Study

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention - birth cohort study: There are no interventions because it is a birth cohort study

Study summary

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.

Eligibility

Primary outcome measure(s)

• Height — Within 45 days of life
  Height in meters
• Height — at 3 months of age
  Height in meters
• Height — at 6 months of age
  Height in meters
• Height — at 1 year of age
  Height in meters
• Height — at 3 years of age
  Height in meters
• Height — at 6 years of age
  Height in meters
• Weight — Within 45 days of life
  Weight in kilograms
• Weight — At 3 months of life
  Weight in kilograms
• Weight — At 6 months of life
  Weight in kilograms
• Weight — At 1 year of life
  Weight in kilograms
• Weight — At 3 years of life
  Weight in kilograms
• Weight — At 6 years of life
  Weight in kilograms
• Child development — At 6 months 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.
• Child development — At 1 year 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.
• Child development — At 2 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.
• Child development — At 3 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.
• Child development — 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 — At 3 years of life
  Measured as BMI in kg/m\^2
• Incidence of child overweight and obesity — At 6 years of life
  Measured as BMI in kg/m\^2
• Duration of exclusive breastfeeding — Within 45 days of life
  The paediatrician will ask the mother if she is still exclusively breastfeeding
• Duration of exclusive breastfeeding — At 3 months of life
  The paediatrician will ask the mother if she is still exclusively breastfeeding
• Duration of exclusive breastfeeding — At 6 months of life
  The paediatrician will ask the mother if she is still exclusively breastfeeding
• Number of children with wheezing episodes — At 2 years of life
  Number of children who have had at least one wheezing episode
• Number of children with wheezing episodes — At 3 years of life
  Number of children who have had at least one wheezing episode
• Number of children with asthma — At 6 years of life
  Number of children who have asthma
• Number of respiratory tract infection episodes in the preschool period — At 1 year of life
  Number of respiratory tract infection episodes
• Number of respiratory tract infection episodes in the preschool period — At 2 years of life
  Number of respiratory tract infection episodes
• Number of respiratory tract infection episodes in the preschool period — At 3 years of life
  Number of respiratory tract infection episodes
• Number of respiratory tract infection episodes in the preschool period — At 6 years of life
  Number of respiratory tract infection episodes
• Number of hospitalizations — At 1 year of life
  The paediatrician will ask the mother about the number of hospitalizations
• Number of hospitalizations — At 2 years of life
  The paediatrician will ask the mother about the number of hospitalizations
• Number of hospitalizations — At 6 years of life
  The paediatrician will ask the mother about the number of hospitalizations
• Childhood vaccinations — At 3 months of life
  The paediatrician will note which vaccines the child has received so far
• Childhood vaccinations — At 6 months of life
  The paediatrician will note which vaccines the child has received so far
• Childhood vaccinations — At 1 year of life
  The paediatrician will note which vaccines the child has received so far
• Childhood vaccinations — At 2 years of life
  The paediatrician will note which vaccines the child has received so far
• Childhood vaccinations — At 6 years of life
  The paediatrician will note which vaccines the child has received so far
• Maternal vaccinations in pregnancy — Within 45 days of life of the child
  The paediatrician will ask the mothers which vaccines they received during the pregnancy

Trial sites (1)

More Mario Negri Institute for Pharmacological Research trials in Italy

Other trials for the same condition