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NASCITA Italian Birth Cohort Study: a Study Protocol (NASCITA)

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ClinicalTrials.gov Identifier: NCT03894566
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.


Condition or disease Intervention/treatment
Social Determinants of Health Health Knowledge, Attitudes, Practice Development, Child Mental Disorders Nutrition Disorders Communicable Diseases Other: No intervention - birth cohort study

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NASCITA Italian Birth Cohort Study: a Study Protocol
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Intervention Details:
  • Other: No intervention - birth cohort study
    There are no interventions because it is a birth cohort study


Primary Outcome Measures :
  1. Height [ Time Frame: Within 45 days of life ]
    Height in meters

  2. Height [ Time Frame: at 3 months of age ]
    Height in meters

  3. Height [ Time Frame: at 6 months of age ]
    Height in meters

  4. Height [ Time Frame: at 1 year of age ]
    Height in meters

  5. Height [ Time Frame: at 3 years of age ]
    Height in meters

  6. Height [ Time Frame: at 6 years of age ]
    Height in meters

  7. Weight [ Time Frame: Within 45 days of life ]
    Weight in kilograms

  8. Weight [ Time Frame: At 3 months of life ]
    Weight in kilograms

  9. Weight [ Time Frame: At 6 months of life ]
    Weight in kilograms

  10. Weight [ Time Frame: At 1 year of life ]
    Weight in kilograms

  11. Weight [ Time Frame: At 3 years of life ]
    Weight in kilograms

  12. Weight [ Time Frame: At 6 years of life ]
    Weight in kilograms

  13. Child development [ Time Frame: 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.

  14. Child development [ Time Frame: 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.

  15. Child development [ Time Frame: 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.

  16. Child development [ Time Frame: 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.

  17. Child development [ Time Frame: 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.

  18. Incidence of child overweight and obesity [ Time Frame: At 3 years of life ]
    Measured as BMI in kg/m^2

  19. Incidence of child overweight and obesity [ Time Frame: At 6 years of life ]
    Measured as BMI in kg/m^2

  20. Duration of exclusive breastfeeding [ Time Frame: Within 45 days of life ]
    The paediatrician will ask the mother if she is still exclusively breastfeeding

  21. Duration of exclusive breastfeeding [ Time Frame: At 3 months of life ]
    The paediatrician will ask the mother if she is still exclusively breastfeeding

  22. Duration of exclusive breastfeeding [ Time Frame: At 6 months of life ]
    The paediatrician will ask the mother if she is still exclusively breastfeeding

  23. Number of children with wheezing episodes [ Time Frame: At 2 years of life ]
    Number of children who have had at least one wheezing episode

  24. Number of children with wheezing episodes [ Time Frame: At 3 years of life ]
    Number of children who have had at least one wheezing episode

  25. Number of children with asthma [ Time Frame: At 6 years of life ]
    Number of children who have asthma

  26. Number of respiratory tract infection episodes in the preschool period [ Time Frame: At 1 year of life ]
    Number of respiratory tract infection episodes

  27. Number of respiratory tract infection episodes in the preschool period [ Time Frame: At 2 years of life ]
    Number of respiratory tract infection episodes

  28. Number of respiratory tract infection episodes in the preschool period [ Time Frame: At 3 years of life ]
    Number of respiratory tract infection episodes

  29. Number of respiratory tract infection episodes in the preschool period [ Time Frame: At 6 years of life ]
    Number of respiratory tract infection episodes

  30. Number of hospitalizations [ Time Frame: At 1 year of life ]
    The paediatrician will ask the mother about the number of hospitalizations

  31. Number of hospitalizations [ Time Frame: At 2 years of life ]
    The paediatrician will ask the mother about the number of hospitalizations

  32. Number of hospitalizations [ Time Frame: At 6 years of life ]
    The paediatrician will ask the mother about the number of hospitalizations

  33. Childhood vaccinations [ Time Frame: At 3 months of life ]
    The paediatrician will note which vaccines the child has received so far

  34. Childhood vaccinations [ Time Frame: At 6 months of life ]
    The paediatrician will note which vaccines the child has received so far

  35. Childhood vaccinations [ Time Frame: At 1 year of life ]
    The paediatrician will note which vaccines the child has received so far

  36. Childhood vaccinations [ Time Frame: At 2 years of life ]
    The paediatrician will note which vaccines the child has received so far

  37. Childhood vaccinations [ Time Frame: At 6 years of life ]
    The paediatrician will note which vaccines the child has received so far

  38. Maternal vaccinations in pregnancy [ Time Frame: Within 45 days of life of the child ]
    The paediatrician will ask the mothers which vaccines they received during the pregnancy


Secondary Outcome Measures :
  1. Hearing test [ Time Frame: At 6 months of life ]
    Assessed with the Boel test



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Days   (Child)
Sexes Eligible for Study:   All
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Children not born in Italy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894566


Contacts
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Contact: Antonio Clavenna, MD, PhD 0039 0239014 ext 559 antonio.clavenna@marionegri.it
Contact: Claudia Pansieri, Pharm.D. 0039 0239014 ext 246 claudia.pansieri@marionegri.it

Locations
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Italy
Istituto di Ricerche Farmacologiche Mario Negri IRCCS Recruiting
Milan, Italy, 20156
Contact: Antonio Clavenna, MD    0039 0239014253    coortenascita@marionegri.it   
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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Study Director: Maurizio Bonati, MD Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Study Chair: Claudia Pansieri, PharmD Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Study Chair: Antonio Clavenna, MD Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Study Chair: Chiara Pandolfini, B.A., PhD Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Additional Information:
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03894566     History of Changes
Other Study ID Numbers: NASCITA
IRFMN 304 ( Registry Identifier: Mario Negri Clinical Trials Registry )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The scientific committee will evaluate single requests for data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mario Negri Institute for Pharmacological Research:
Clinical Trial Protocol [Publication Type];
Cohort Studies
Infant, Newborn
Child
Infant
Health
Public Health
Predictors

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Nutrition Disorders
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders