Social Determinants of HealthNASCITANCT03894566
NASCITA Italian Birth Cohort Study
An observational study of Social Determinants of Health and Health Knowledge, Attitudes, Practice, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 days
- Conditions the study is for
- Social Determinants of Health, Health Knowledge, Attitudes, Practice, Development, Child
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 days
- All sexes
- Child
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.
Who may be able to join
- 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
Who cannot join
- Children not born in Italy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Milan, Milan, 20156
About this study
Official title: NASCITA (Nascere e Crescere in Italia): an Italian Birth Cohort Study
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.
Read more
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.
Read the detailed description
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.
More specifically:
- To evaluate child development through the monitoring of domains that affect nurturing care during the preschool period: health (disease prevention and treatment), nutrition (breastfeeding and dietary approach), safety and security (care and early intervention for vulnerable children), responsive caregiving (caregiving routine), and early learning (home opportunities to explore and learn);
- to identify potential factors influencing child well-being and growth and development, including the acquisition of competences.
The study population of the NASCITA cohort study will consist of children born in Italy during a one-year period who will be followed prospectively by participating pediatricians until at least the age of 6 years and whose parents agree to participate.
In Italy the large North-South divide is a major factor of socio-economic weakness and can be noted by the huge difference in statistical income between the northern and southern regions and municipalities.
Organization The coordination of the NASCITA study will be provided by the team of the Laboratory for Mother and Child Health of the Mario Negri Research Institute that integrates different expertise and competence with a long-standing experience in multicenter clinical research. The coordinating center will also carry out data collection, storage, management, and analysis. An independent scientific committee consisting of representatives of different disciplines and realities (including lay people) will monitor the development and results of the project.
NASCITA will be embedded in Italian pediatric primary care practice. A network of local contacts between pediatricians has been set up so that each node, representative of a setting, will act as a bridge to the coordinating center in conducting the study.
Recruitment The network that the study coordination center has built over the years involving hundreds of family pediatricians, documented by numerous collaborative publications, represents the first interlocutor to whom to propose participation in the study. The national Pediatric Cultural Association (ACP), with about 2000 members consisting mainly of family pediatricians, is among the supporters of the study. Pediatric scientific societies and associations will be contacted because detailed information concerning the study will be disseminated through national pediatric journals and internet-based resources. Recruitment will be based on the voluntary participation of interested pediatricians who can guarantee seven years of professional activity so that they can follow the enrolled newborns for the whole study period. This approach to enrolling pediatricians can be defined as a mixed method using also non-probability sampling techniques (convenience and purposive sampling) applied to choose a sample of subjects/units from a population.
Twenty-three geographic clusters were identified as representative of the country based on geographic and socio-economic characteristics and administrative divisions. Pediatricians and newborns of all the 23 identified clusters will be involved in the study.
Recruitment of the newborns (and their parents) will take place during the first routine well child visit scheduled for all newborns within their first 45 days of life at the office of the pediatrician assigned to them by the Local Health Units (LHU) to which they belong. Parents will receive oral and written information about the purpose and methods of the study and will be invited to participate.If they agree to participate, they will be asked to sign an informed consent. Recruitment of newborns will start in the first half of 2019, while recruitment of pediatricians will start in the preceding months.
Training and tutorial activities Before the start of the study, family pediatricians will be involved in training activities. Local coordinators will be trained by the research team, and will be responsible for the training of their peers at the local level. A CRF (case report form) was created in an online form with the contribution of local representatives of family pediatricians and scientific committee participants. During an initial phase, a group of family pediatricians tested the electronic CRF (eCRF), leading to improvements and adding the necessary questions to achieve an eCRF that would allow a more complete and simple collection of data. The eCRF will be available online before the start of the enrolment period in order to let participating family pediatricians familiarize with the information that needs to be collected.
Central and local monitoring of the study will be scheduled with the aim to guarantee follow up of the infants and the quality of data collected.
Data collection Data considered for the basic CRF are part of those routinely collected by the family pediatricians at the 7 standard well-child visits scheduled for all children during their first 6 years of life, and data collected during each contact with the enrolled children. However, expansion of the eCRF for specific research interests that may occur during the study period is foreseen. In order to enhance the quality of the data, the eCRF includes consistency and range checks to prevent internal inconsistencies, although the continuing review of collected data is guaranteed by the coordinating center and, in case of inconsistencies, pediatricians will be contacted. The administrators of the website (the coordinating center) will be able to view the completed forms also in a graphic format that will be updated periodically.
Baseline data At the first visit (within 45 days of life of the newborn), parents will be asked about parental medical history, characteristics and lifestyle, indoor and outdoor environment, and circumstances during pregnancy and around birth. Pregnancy and perinatal data will be collected also through hospital discharge documents following delivery.
Study population size The NASCITA cohort is sized to have enough power to study relatively common childhood exposures and outcomes, based on the national prevalence of certain health characteristics of Italian children and the expected number of cases for different enrolling scenarios. The aim is to recruit no less than 5000, and hopefully at least 10,000, newborns with complete information collected over the period of the study.
Analysis plan
In line with the aims of the study, univariate and multivariate analyses will be performed in an ongoing manner to investigate several associations in order to provide an answer to a number of research questions, including:
- the association between prenatal and living setting determinants and child neurocognitive development and health;
- the relationship between pregnancy, perinatal, and newborn growth characteristics and occurrence of adverse outcomes (i.e., obesity, hypertension, wheezing, eczema, hay fever, and asthma);
- the relationship between newborn and child nutrition quality and occurrence of overweight and obesity;
- the association between early stimulating learning initiatives and neurodevelopment of enrolled children;
- the association between vaccination and prevalence of preventable infectious diseases;
- the association between lifestyle factors and health inequalities and the trajectory of health in the preschool period.
Migrant newborns will be included in a special subgroup of analyses.
Materials produced A specific web portal for the NASCITA cohort study was developed (https://coortenascita.marionegri.it) to collect data, through a web-based form, and to provide findings and other information during the study period, also with the use of graphics on the analyses and data collected based on a successful approach already reported by the coordinating center.
Ethics and dissemination A consent form for participation will be signed by the pediatricians upon their first access to the web site. A paper consent form will be signed by parents at the first visit. This form includes the consent to data collection at each contact with the pediatrician during the six-year study period (first 6 years of the child's life). The filled in consent form will be stored by the pediatrician for ten years. Withdrawal from the study is guaranteed at any time both to pediatricians and parents. When consent is withdrawn, the child's data collected up to that point will be kept in the analyses, but no further data will be collected. Standard procedures for the protection of confidential individual information will be applied according to national and international ethical recommendations and guidelines as well as national legal regulations. Data will be pseudonymized and all analyses will be conducted with fully anonymized data sets.
A newsletter report will periodically be sent to the pediatricians and uploaded on the web site. During the study, different tools will be used to update the participating families mainly through the web site. Collected data will be periodically analyzed according to the aims of the project, and findings reported to lay people and the scientific community.
When the enrolled children reach the age of 6 years, if not decided otherwise in the meantime, their personal files will no longer be updated, but will be kept for another 10 years in the database.
NASCITA proposes to be a resource for the research community, so data will be available to public researchers outside the NASCITA research group upon request for collaborative research initiatives, after approval by the scientific committee.
- Conditions
- Social Determinants of Health, Health Knowledge, Attitudes, Practice, Development, Child, Mental Disorders, Nutrition Disorders, Communicable Diseases
- Being tested
- No intervention - birth cohort study
- Keywords
- Clinical Trial Protocol [Publication Type];, Cohort Studies, Infant, Newborn, Child, Infant, Health, Public Health, Predictors
- Medical subject headings
- Behavior, Mental Disorders, Nutrition Disorders, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - birth cohort studyOther
There are no interventions because it is a birth cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Height in meters
Measured: Within 45 days of life
Height
Height in meters
Measured: at 3 months of age
Height
Height in meters
Measured: at 6 months of age
Height
Height in meters
Measured: at 1 year of age
Height
Height in meters
Measured: at 3 years of age
Height
Height in meters
Measured: at 6 years of age
Weight
Weight in kilograms
Measured: Within 45 days of life
Weight
Weight in kilograms
Measured: At 3 months of life
Weight
Weight in kilograms
Measured: At 6 months of life
Weight
Weight in kilograms
Measured: At 1 year of life
Weight
Weight in kilograms
Measured: At 3 years of life
Weight
Weight in kilograms
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 years of life
Incidence of child overweight and obesity
Measured as BMI in kg/m^2
Measured: At 3 years of life
Incidence of child overweight and obesity
Measured as BMI in kg/m^2
Measured: At 6 years of life
Duration of exclusive breastfeeding
The paediatrician will ask the mother if she is still exclusively breastfeeding
Measured: Within 45 days of life
Duration of exclusive breastfeeding
The paediatrician will ask the mother if she is still exclusively breastfeeding
Measured: At 3 months of life
Duration of exclusive breastfeeding
The paediatrician will ask the mother if she is still exclusively breastfeeding
Measured: At 6 months of life
Number of children with wheezing episodes
Number of children who have had at least one wheezing episode
Measured: At 2 years of life
Number of children with wheezing episodes
Number of children who have had at least one wheezing episode
Measured: At 3 years of life
Number of children with asthma
Number of children who have asthma
Measured: At 6 years of life
Number of respiratory tract infection episodes in the preschool period
Number of respiratory tract infection episodes
Measured: At 1 year of life
Number of respiratory tract infection episodes in the preschool period
Number of respiratory tract infection episodes
Measured: At 2 years of life
Number of respiratory tract infection episodes in the preschool period
Number of respiratory tract infection episodes
Measured: At 3 years of life
Number of respiratory tract infection episodes in the preschool period
Number of respiratory tract infection episodes
Measured: At 6 years of life
Number of hospitalizations
The paediatrician will ask the mother about the number of hospitalizations
Measured: At 1 year of life
Number of hospitalizations
The paediatrician will ask the mother about the number of hospitalizations
Measured: At 2 years of life
Number of hospitalizations
The paediatrician will ask the mother about the number of hospitalizations
Measured: At 6 years of life
Childhood vaccinations
The paediatrician will note which vaccines the child has received so far
Measured: At 3 months of life
Childhood vaccinations
The paediatrician will note which vaccines the child has received so far
Measured: At 6 months of life
Childhood vaccinations
The paediatrician will note which vaccines the child has received so far
Measured: At 1 year of life
Childhood vaccinations
The paediatrician will note which vaccines the child has received so far
Measured: At 2 years of life
Childhood vaccinations
The paediatrician will note which vaccines the child has received so far
Measured: At 6 years of life
Maternal vaccinations in pregnancy
The paediatrician will ask the mothers which vaccines they received during the pregnancy
Measured: Within 45 days of life of the child
Secondary outcomes (1)
Hearing test
Assessed with the Boel test
Measured: At 6 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2023
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Bonati, MD, Study director, Istituto Di Ricerche Farmacologiche Mario NegriAntonio Clavenna, MD, PhD, Study chair, Istituto Di Ricerche Farmacologiche Mario NegriChiara Pandolfini, BA, PhD, Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894566
- Sponsor's protocol ID
- NASCITA
- Other IDs
- IRFMN 304
- Acronym
- NASCITA
- Status last verified
- Nov 2024
- First submitted
- 12 Mar 2019
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The scientific committee will evaluate single requests for data
Publications
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.
PubMed 32075601Zanetti 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.
PubMed 33709930Pandolfini 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.
PubMed 38644455Pandolfini 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.
PubMed 36379649Clavenna 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.
PubMed 36625429Segre 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.
PubMed 37355274
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NASCITA (Nascere e Crescere in Italia): an Italian Birth Cohort Study
- ClinicalTrials.gov ID
- NCT03894566
- Acronym / sponsor ID
- NASCITA / NASCITA
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
More specifically:
- To evaluate child development through the monitoring of domains that affect nurturing care during the preschool period: health (disease prevention and treatment), nutrition (breastfeeding and dietary approach), safety and security (care and early intervention for vulnerable children), responsive caregiving (caregiving routine), and early learning (home opportunities to explore and learn);
- to identify potential factors influencing child well-being and growth and development, including the acquisition of competences.
The study population of the NASCITA cohort study will consist of children born in Italy during a one-year period who will be followed prospectively by participating pediatricians until at least the age of 6 years and whose parents agree to participate.
In Italy the large North-South divide is a major factor of socio-economic weakness and can be noted by the huge difference in statistical income between the northern and southern regions and municipalities.
Organization The coordination of the NASCITA study will be provided by the team of the Laboratory for Mother and Child Health of the Mario Negri Research Institute that integrates different expertise and competence with a long-standing experience in multicenter clinical research. The coordinating center will also carry out data collection, storage, management, and analysis. An independent scientific committee consisting of representatives of different disciplines and realities (including lay people) will monitor the development and results of the project.
NASCITA will be embedded in Italian pediatric primary care practice. A network of local contacts between pediatricians has been set up so that each node, representative of a setting, will act as a bridge to the coordinating center in conducting the study.
Recruitment The network that the study coordination center has built over the years involving hundreds of family pediatricians, documented by numerous collaborative publications, represents the first interlocutor to whom to propose participation in the study. The national Pediatric Cultural Association (ACP), with about 2000 members consisting mainly of family pediatricians, is among the supporters of the study. Pediatric scientific societies and associations will be contacted because detailed information concerning the study will be disseminated through national pediatric journals and internet-based resources. Recruitment will be based on the voluntary participation of interested pediatricians who can guarantee seven years of professional activity so that they can follow the enrolled newborns for the whole study period. This approach to enrolling pediatricians can be defined as a mixed method using also non-probability sampling techniques (convenience and purposive sampling) applied to choose a sample of subjects/units from a population.
Twenty-three geographic clusters were identified as representative of the country based on geographic and socio-economic characteristics and administrative divisions. Pediatricians and newborns of all the 23 identified clusters will be involved in the study.
Recruitment of the newborns (and their parents) will take place during the first routine well child visit scheduled for all newborns within their first 45 days of life at the office of the pediatrician assigned to them by the Local Health Units (LHU) to which they belong. Parents will receive oral and written information about the purpose and methods of the study and will be invited to participate.If they agree to participate, they will be asked to sign an informed consent. Recruitment of newborns will start in the first half of 2019, while recruitment of pediatricians will start in the preceding months.
Training and tutorial activities Before the start of the study, family pediatricians will be involved in training activities. Local coordinators will be trained by the research team, and will be responsible for the training of their peers at the local level. A CRF (case report form) was created in an online form with the contribution of local representatives of family pediatricians and scientific committee participants. During an initial phase, a group of family pediatricians tested the electronic CRF (eCRF), leading to improvements and adding the necessary questions to achieve an eCRF that would allow a more complete and simple collection of data. The eCRF will be available online before the start of the enrolment period in order to let participating family pediatricians familiarize with the information that needs to be collected.
Central and local monitoring of the study will be scheduled with the aim to guarantee follow up of the infants and the quality of data collected.
Data collection Data considered for the basic CRF are part of those routinely collected by the family pediatricians at the 7 standard well-child visits scheduled for all children during their first 6 years of life, and data collected during each contact with the enrolled children. However, expansion of the eCRF for specific research interests that may occur during the study period is foreseen. In order to enhance the quality of the data, the eCRF includes consistency and range checks to prevent internal inconsistencies, although the continuing review of collected data is guaranteed by the coordinating center and, in case of inconsistencies, pediatricians will be contacted. The administrators of the website (the coordinating center) will be able to view the completed forms also in a graphic format that will be updated periodically.
Baseline data At the first visit (within 45 days of life of the newborn), parents will be asked about parental medical history, characteristics and lifestyle, indoor and outdoor environment, and circumstances during pregnancy and around birth. Pregnancy and perinatal data will be collected also through hospital discharge documents following delivery.
Study population size The NASCITA cohort is sized to have enough power to study relatively common childhood exposures and outcomes, based on the national prevalence of certain health characteristics of Italian children and the expected number of cases for different enrolling scenarios. The aim is to recruit no less than 5000, and hopefully at least 10,000, newborns with complete information collected over the period of the study.
Analysis plan
In line with the aims of the study, univariate and multivariate analyses will be performed in an ongoing manner to investigate several associations in order to provide an answer to a number of research questions, including:
- the association between prenatal and living setting determinants and child neurocognitive development and health;
- the relationship between pregnancy, perinatal, and newborn growth characteristics and occurrence of adverse outcomes (i.e., obesity, hypertension, wheezing, eczema, hay fever, and asthma);
- the relationship between newborn and child nutrition quality and occurrence of overweight and obesity;
- the association between early stimulating learning initiatives and neurodevelopment of enrolled children;
- the association between vaccination and prevalence of preventable infectious diseases;
- the association between lifestyle factors and health inequalities and the trajectory of health in the preschool period.
Migrant newborns will be included in a special subgroup of analyses.
Materials produced A specific web portal for the NASCITA cohort study was developed (https://coortenascita.marionegri.it) to collect data, through a web-based form, and to provide findings and other information during the study period, also with the use of graphics on the analyses and data collected based on a successful approach already reported by the coordinating center.
Ethics and dissemination A consent form for participation will be signed by the pediatricians upon their first access to the web site. A paper consent form will be signed by parents at the first visit. This form includes the consent to data collection at each contact with the pediatrician during the six-year study period (first 6 years of the child's life). The filled in consent form will be stored by the pediatrician for ten years. Withdrawal from the study is guaranteed at any time both to pediatricians and parents. When consent is withdrawn, the child's data collected up to that point will be kept in the analyses, but no further data will be collected. Standard procedures for the protection of confidential individual information will be applied according to national and international ethical recommendations and guidelines as well as national legal regulations. Data will be pseudonymized and all analyses will be conducted with fully anonymized data sets.
A newsletter report will periodically be sent to the pediatricians and uploaded on the web site. During the study, different tools will be used to update the participating families mainly through the web site. Collected data will be periodically analyzed according to the aims of the project, and findings reported to lay people and the scientific community.
When the enrolled children reach the age of 6 years, if not decided otherwise in the meantime, their personal files will no longer be updated, but will be kept for another 10 years in the database.
NASCITA proposes to be a resource for the research community, so data will be available to public researchers outside the NASCITA research group upon request for collaborative research initiatives, after approval by the scientific committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 45 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children not born in Italy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - birth cohort studyThere are no interventions because it is a birth cohort study | Other | – |
Primary outcome
Height
Time frame: Within 45 days of life
Height in meters
Height
Time frame: at 3 months of age
Height in meters
Height
Time frame: at 6 months of age
Height in meters
Height
Time frame: at 1 year of age
Height in meters
Height
Time frame: at 3 years of age
Height in meters
Height
Time frame: at 6 years of age
Height in meters
Weight
Time frame: Within 45 days of life
Weight in kilograms
Weight
Time frame: At 3 months of life
Weight in kilograms
Weight
Time frame: At 6 months of life
Weight in kilograms
Weight
Time frame: At 1 year of life
Weight in kilograms
Weight
Time frame: At 3 years of life
Weight in kilograms
Weight
Time frame: At 6 years of life
Weight in kilograms
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.
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.
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.
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.
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.
Incidence of child overweight and obesity
Time frame: At 3 years of life
Measured as BMI in kg/m^2
Incidence of child overweight and obesity
Time frame: At 6 years of life
Measured as BMI in kg/m^2
Duration of exclusive breastfeeding
Time frame: Within 45 days of life
The paediatrician will ask the mother if she is still exclusively breastfeeding
Duration of exclusive breastfeeding
Time frame: At 3 months of life
The paediatrician will ask the mother if she is still exclusively breastfeeding
Duration of exclusive breastfeeding
Time frame: At 6 months of life
The paediatrician will ask the mother if she is still exclusively breastfeeding
Number of children with wheezing episodes
Time frame: At 2 years of life
Number of children who have had at least one wheezing episode
Number of children with wheezing episodes
Time frame: At 3 years of life
Number of children who have had at least one wheezing episode
Number of children with asthma
Time frame: At 6 years of life
Number of children who have asthma
Number of respiratory tract infection episodes in the preschool period
Time frame: At 1 year of life
Number of respiratory tract infection episodes
Number of respiratory tract infection episodes in the preschool period
Time frame: At 2 years of life
Number of respiratory tract infection episodes
Number of respiratory tract infection episodes in the preschool period
Time frame: At 3 years of life
Number of respiratory tract infection episodes
Number of respiratory tract infection episodes in the preschool period
Time frame: At 6 years of life
Number of respiratory tract infection episodes
Number of hospitalizations
Time frame: At 1 year of life
The paediatrician will ask the mother about the number of hospitalizations
Number of hospitalizations
Time frame: At 2 years of life
The paediatrician will ask the mother about the number of hospitalizations
Number of hospitalizations
Time frame: At 6 years of life
The paediatrician will ask the mother about the number of hospitalizations
Childhood vaccinations
Time frame: At 3 months of life
The paediatrician will note which vaccines the child has received so far
Childhood vaccinations
Time frame: At 6 months of life
The paediatrician will note which vaccines the child has received so far
Childhood vaccinations
Time frame: At 1 year of life
The paediatrician will note which vaccines the child has received so far
Childhood vaccinations
Time frame: At 2 years of life
The paediatrician will note which vaccines the child has received so far
Childhood vaccinations
Time frame: At 6 years of life
The paediatrician will note which vaccines the child has received so far
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
1 secondary outcome
Hearing test
Time frame: At 6 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 32075601Pansieri 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.
- Background: PubMed 33709930Zanetti 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.
- Results publication: PubMed 38644455Pandolfini 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.
- Results publication: PubMed 36379649Pandolfini 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.
- Results publication: PubMed 36625429Clavenna 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.
- Derived from this study: PubMed 37355274Segre 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.
- NASCITA Cohort websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The scientific committee will evaluate single requests for data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Bonati, MD study director
Istituto Di Ricerche Farmacologiche Mario Negri
Antonio Clavenna, MD, PhD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
Chiara Pandolfini, BA, PhD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Determinants of Health and Health Knowledge, Attitudes, Practice, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: Within 45 days of life). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894566, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.