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Date of filling in this questionnaire or last update: 02/11/2020
1. IDENTIFICATION & BASIC DESCRIPTION
Cohort name
  Piccolipiù
Country
 

  • Italy
Name
  Daniela Porta
Institution
  Department of Epidemiology of the Regional Health Service - Lazio
Email
  d.porta@deplazio.it
Phone
  06.99722188
Personal website
  https://www.deplazio.net
Website
 

  • http://www.piccolipiu.it/
Name of committee
  ETHICAL COMMITTEE OF A.U.S.L ROMA E
Upload files
 

Contact Principal Investigator (name)
  Daniela Porta
Data access policy (briefly describe)
  The Steering Committee (five people) can evaluate the proposal submitted for analysis and publications.
Is this cohort part of a consortium? (name consortium)
  the consortium is not already completed
Participation in pooled analyses
 

  • The cohort is potentially interested in participating in pooled analyses of (European) occupational cohort studies (note pooled analyses also includes remote decentralized analyses that would not require any transfer of primary data as well as meta-analyses).
Main aim of cohort, please briefly describe the main objectives of the cohort
  To estimate the association between perinatal and early life factors, and environmental, social, occupational, factors and asthma and respiratory symptoms, obesity and metabolic disorders, cognitive development; to describe the complex interactions between genetic, epigenetic, lifestyle factors and the environment. The cohort built a biobank with samples of serum and plasma from maternal and cord blood; umbilical cord; heel blood spot. Piccolipiù cohort is based on five cities of Northern and Central italy
Source population (please select as many as appropriate)
 

  • Mother-child cohort
Comparators (please select as many as appropriate)
 

  • Internal study population
Inclusion criteria
  Are at least eighteen years old; are resident in the catchment area of the maternity centres; have enough knowledge of the Italian language to adequately understand the informed consent and to complete the questionnaires; have at least a telephone number they can be reached at.
Enrollment
  Completed
Age range at entry (main cohort)
 

Minimum Maximum Mean
16 49 34

Age range at entry (subcohort)
 

Minimum Maximum Mean Please describe
16 47 34
17 49 34
19 47 34
19 49 34

Men at enrollment
  3358
Women at enrollment
  3358
Children (<18 years) at enrollment
  3358
Men at last follow-up
  2751
Women at last follow-up
  2751
Children (<18 years) at last follow-up
  2751
Comments
  All pregnant women and their partners are invited to participate in the study during the pregnancy. Mothers are contacted at 6, 12, 24 months, 4 years and 6 years after delivery to collect follow-up information through questionnaires and medical examination in an outpatient clinic. Non respondents are repeatedly solicited by e-mail, SMS, telephone or regular mail following a predefined protocol.
2. OUTCOME FOLLOW-UP
Type of data for outcome follow-up (please select as many as appropriate)
 

  • Active (contact with participants)
Active (contact with participants) (specify)
 

  • Mothers are contacted at 6, 12 and 24 months, 4 years and 6 years after delivery to collect follow-up information through questionnaires and medical examination in an outpatient clinic.
First follow-up period (provide year)
  2011
Last follow-up period (provide year)
  2018
Number of follow-ups after baseline (provide number)
  5
3. OCCUPATIONAL EXPOSURES
Source of exposure data collected (please select as many as appropriate)
 

  • Questionnaire, Personal (Self-reporting or interview)
Occupational history/time frame
  Follow-up period
Occupational coding performed
  No
Methods for exposure assessment (please select as many as appropriate)
 

  • Self-report
Main categories
 

  • Organisation of work including working time
Organisation of work including working time | Employment conditions
 

  • Job insecurity
  • Lack of access to benefits, collective bargaining, social protection
  • Work contract type (i.e. permanent, term-contract, subcontract, temporary)
Organisation of work including working time | Shift work
 

  • Night (permanent or rotating)
4. OUTCOMES EVALUATED
Baseline - type of outcome data collected (select more than one if applicable)
 

  • Biomarker (specify)
  • Questionnaire, individual (self-recording or interview)
Specify: Biomarker
  mother blood samples at delivery, mother cord blood, cord sample
Follow-up - type of outcome data collected (select more than one if applicable)
 

  • Questionnaire, individual (self-recording or interview)
Outcome type (please select as many as appropriate)
 

  • Morbidity
  • Disability
Diagnostic groups based on ICD10
 

  • A Bacterial infectious disease, type of microorganisms*
  • B Viral infections, type of microorganisms*
  • E Endocrinological disease
  • E Metabolism disease
  • F Mental disorders
  • G Disease in the nervous system
  • H Disorders of the eye
  • J Respiratory disease
  • O+P Pregnancy and labour
  • Q After birth – child disorders
A Bacterial infectious disease, type of microorganisms*
 

  • Streptococcus
  • Toxoplasma gondii
B Viral infections, type of microorganisms
 

  • Cytomegalovirus
  • Hepatitis (A,B,C,E)
  • Varicella zoster virus
E Endocrinological disease
 

  • Thyroidea
  • Diabetes mellitus
E Metabolism disease
 

  • Lactose intolerance
  • Cystic fibrosis
F Mental disorders
 

  • Depression
  • Eating disorders
  • Other, please state
F Mental disorders | Other (specify)
  anxiety
G Disease in the nervous system
 

  • Epilepsy
  • Migraine
H Disorders of the eye
 

  • Other, please state
H Disorders of the eye | Other (specify)
  myopia
J Respiratory disease
 

  • Pneumonia due to other infectious organisms, not elsewhere classified
  • Chronic Bronchitis
  • Asthma
  • Other, please state
J Respiratory disease | Other (specify)
  asthmatic bronchitis
O+P Pregnancy and labour
 

  • Eclampsia in pregnancy, labour or puerperium
  • Venous complications in pregnancy
  • Infections of genito-urinary tract in pregnancy
  • Diabetes mellitus in pregnancy
  • Other specified pregnancy-related conditions
  • Preterm delivery
  • Extremely low birth weight
  • Other low birth weight
  • Congenital viral diseases
  • Other, please state
O+P Pregnancy and labour | Other (specify)
  Polyhydramnios, Oligohydramnios
Q After birth – child disorders
 

  • Congenital malformations of the nervous system incl. the brain
  • Congenital malformations of the circulatory system
  • Congenital malformations of the respiratory system
  • Cleft lip and cleft palate
  • Congenital malformations of digestive system
  • Congenital malformations of genital organs
  • Congenital malformations of the urinary system
  • Congenital malformations and deformations of the musculoskeletal system
  • Down's syndrome
  • Turner's syndrome
  • Klinefelter's syndrome
5. BIOLOGICAL SAMPLES & ANALYSIS
Biological samples collected
 

  • Blood
  • Other
Specify: Other
  cord blood, cord slice
Biological processing
 

  • DNA
Genetic and other lab analyses
 

  • Epigenomics
  • Genomics / GWAS
  • Genomics / Other genetics (specify)
Specify: Other genetics
  Telomere length analysis
6. Other Information
 

  • Alcohol
  • Anthropometry
  • Demographics
  • Diet
  • Education
  • Environmental, air pollution
  • Environmental other (specify)
  • Medical history
  • Physical exercise
  • Residential history
  • Socioeconomic status
  • Smoking
  • Other (specify)
Specify: Environmental other
  noise
Specify: Other
  General Health Questionnaire (ghq-12 scale) administered to mothers at baseline and during follow-up
Possibility for linkage to data registries/data enrichment via data linkage
 

  • Birth register
  • Cancer incidence
  • Disease specific clinical database
  • Hospital discharge
  • Medication usage
  • Mortality register
  • Other (specify)
Specify: Other
  available only for some sub-cohorts depending on the city