NASCITA Italian Birth Cohort Study

NCT03894566 | Active Not Recruiting DMC

• 2 other identifiers: NASCITAIRFMN 304
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Determinants of Health; Health Knowledge, Attitudes, Practice; Development, Child; Mental Disorders; Nutrition Disorders; Communicable Diseases

Keywords

Clinical Trial Protocol [Publication Type];; Cohort Studies; Infant, Newborn; Child; Infant; Health; Public Health; Predictors

Outcome Measures

Primary Outcomes (38)

• Height

  Height in meters

  Within 45 days of life

• Height

  Height in meters

  at 3 months of age

• Height

  Height in meters

  at 6 months of age

• Height

  Height in meters

  at 1 year of age

• Height

  Height in meters

  at 3 years of age

• Height

  Height in meters

  at 6 years of age

• Weight

  Weight in kilograms

  Within 45 days of life

• Weight

  Weight in kilograms

  At 3 months of life

• Weight

  Weight in kilograms

  At 6 months of life

• Weight

  Weight in kilograms

  At 1 year of life

• Weight

  Weight in kilograms

  At 3 years of life

• Weight

  Weight in kilograms

  At 6 years of life

• Child development

  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.

  At 6 months of life

• Child development

  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.

  At 1 year of life

• Child development

  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.

  At 2 years of life

• Child development

  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.

  At 3 years of life

• Child development

  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.

  At 6 years of life

• Incidence of child overweight and obesity

  Measured as BMI in kg/m\^2

  At 3 years of life

• Incidence of child overweight and obesity

  Measured as BMI in kg/m\^2

  At 6 years of life

• Duration of exclusive breastfeeding

  The paediatrician will ask the mother if she is still exclusively breastfeeding

  Within 45 days of life

• Duration of exclusive breastfeeding

  The paediatrician will ask the mother if she is still exclusively breastfeeding

  At 3 months of life

• Duration of exclusive breastfeeding

  The paediatrician will ask the mother if she is still exclusively breastfeeding

  At 6 months of life

• Number of children with wheezing episodes

  Number of children who have had at least one wheezing episode

  At 2 years of life

• Number of children with wheezing episodes

  Number of children who have had at least one wheezing episode

  At 3 years of life

• Number of children with asthma

  Number of children who have asthma

  At 6 years of life

• Number of respiratory tract infection episodes in the preschool period

  Number of respiratory tract infection episodes

  At 1 year of life

• Number of respiratory tract infection episodes in the preschool period

  Number of respiratory tract infection episodes

  At 2 years of life

• Number of respiratory tract infection episodes in the preschool period

  Number of respiratory tract infection episodes

  At 3 years of life

• Number of respiratory tract infection episodes in the preschool period

  Number of respiratory tract infection episodes

  At 6 years of life

• Number of hospitalizations

  The paediatrician will ask the mother about the number of hospitalizations

  At 1 year of life

• Number of hospitalizations

  The paediatrician will ask the mother about the number of hospitalizations

  At 2 years of life

• Number of hospitalizations

  The paediatrician will ask the mother about the number of hospitalizations

  At 6 years of life

• Childhood vaccinations

  The paediatrician will note which vaccines the child has received so far

  At 3 months of life

• Childhood vaccinations

  The paediatrician will note which vaccines the child has received so far

  At 6 months of life

• Childhood vaccinations

  The paediatrician will note which vaccines the child has received so far

  At 1 year of life

• Childhood vaccinations

  The paediatrician will note which vaccines the child has received so far

  At 2 years of life

• Childhood vaccinations

  The paediatrician will note which vaccines the child has received so far

  At 6 years of life

• Maternal vaccinations in pregnancy

  The paediatrician will ask the mothers which vaccines they received during the pregnancy

  Within 45 days of life of the child

Secondary Outcomes (1)

• Hearing test

  At 6 months of life

Interventions

No intervention - birth cohort study OTHER

There are no interventions because it is a birth cohort study

Eligibility Criteria

• Age: Up to 45 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Italian healthcare is provided through a network of Local Health Units, each of which consists of multiple healthcare districts. Every Italian resident is registered with a family (pediatric or general) practitioner. In Italy there are about 7500 family pediatricians, for an average of 450.000 births/year. About 60 newborns/year are therefore assigned to each pediatrician. Twenty-two geographic clusters were identified as representative of Italy based on geographic and socio-economic characteristics and administrative divisions. Pediatricians and newborns from all 22 clusters will be involved in the study. From the start of 2019, newborns will be continuously included in the study for an entire one-year period chosen by each pediatrician and will be followed until 6 years of age.

You may qualify if:

• 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

You may not qualify if:

• \- Children not born in Italy

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Milan, Milan, 20156, Italy

Location

Related Publications (6)

• Pandolfini C, Clavenna A, Campi R, Cartabia M, Finazzi S, Bonati M. Parental practices that influence children's development: how often are they implemented and by whom-results from the NASCITA birth cohort study. Eur J Pediatr. 2024 Jul;183(7):3029-3038. doi: 10.1007/s00431-024-05564-w. Epub 2024 Apr 22.

  PMID: 38644455 BACKGROUND

• Pansieri C, Clavenna A, Pandolfini C, Zanetti M, Calati MG, Miglio D, Cartabia M, Zanetto F, Bonati M. NASCITA Italian birth cohort study: a study protocol. BMC Pediatr. 2020 Feb 19;20(1):80. doi: 10.1186/s12887-020-1961-1.

  PMID: 32075601 BACKGROUND

• Zanetti M, Clavenna A, Pandolfini C, Pansieri C, Calati MG, Cartabia M, Miglio D, Bonati M. Informatics Methodology Used in the Web-Based Portal of the NASCITA Cohort Study: Development and Implementation Study. J Med Internet Res. 2021 Mar 12;23(3):e23087. doi: 10.2196/23087.

  PMID: 33709930 BACKGROUND

• Pandolfini C, Clavenna A, Cartabia M, Campi R, Bonati M; NASCITA Work Group. National, longitudinal NASCITA birth cohort study to investigate the health of Italian children and potential influencing factors. BMJ Open. 2022 Nov 15;12(11):e063394. doi: 10.1136/bmjopen-2022-063394.

  PMID: 36379649 BACKGROUND

• Clavenna A, Morabito E, Cartabia M, Campi R, Pandolfini CL, Bonati M; NASCITA Working Group. National, longitudinal NASCITA birth cohort study: prevalence of overweight at 12 months of age in children born healthy. BMJ Paediatr Open. 2023 Jan;7(1):e001622. doi: 10.1136/bmjpo-2022-001622.

  PMID: 36625429 BACKGROUND

• Segre G, Clavenna A, Cartabia M, Bonati M; NASCITA Working Group. Postpartum depression screening in mothers and fathers at well-child visits: a feasibility study within the NASCITA cohort. BMJ Open. 2023 Jun 23;13(6):e069797. doi: 10.1136/bmjopen-2022-069797.

  PMID: 37355274 DERIVED

Related Links

• NASCITA Cohort website

MeSH Terms

Conditions

Behavior; Mental Disorders; Nutrition Disorders; Communicable Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maurizio Bonati, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

• Antonio Clavenna, MD, PhD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

• Chiara Pandolfini, BA, PhD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 28, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: April 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)