Study design



The Piccolipiù study plans to recruit and follow-up a birth cohort of 3,000 children born in selected maternal units located in five Italian cities (Florence, Rome, Trieste, Turin, and Viareggio). Members of the cohort are all babies born to women who:

  1. are at least eighteen years old;
  2. are resident in the catchment area of the maternity centres;
  3. have enough knowledge of the Italian language to adequately understand the informed consent and to complete the questionnaires;
  4. have at least a telephone number they can be reached at.


Recruitment

All pregnant women and their partners are invited to participate in the study at different times during the pregnancy: in Florence, Trieste, Rome, Viareggio they are contacted during antenatal classes, routine visits to prenatal clinics or ultrasound examinations at 26-34 weeks of gestation; in Turin and Rome at admittance to the hospital for delivery.
Biological material is collected, processed and temporarily cryopreserved in the maternity centres and periodically transferred to the Piccolipiù biobank, located at the Istituto Superiore di Sanità (ISS, Italian National Institute of Health), for final storage.
Blood samples from the child’s umbilical cord and three small pieces of umbilical cord are drawn during delivery. During the compulsory neonatal screening test at 48 hours of life, additional heel blood is spotted on filter paper.
In addition, blood samples are drawn from mothers just before or after delivery. Women recruited during pregnancy are invited to complete a baseline questionnaire. The baseline questionnaire is self-administered, except for the sections regarding maternal health during pregnancy, which are completed by a face to face interview with trained personnel after birth, and for the information on the delivery which is obtained from hospital charts review


Follow-up

Mothers are contacted at 6, 12 and 24 months after delivery to collect follow-up information through questionnaires. Non respondents are repeatedly solicited by e-mail, SMS, telephone or regular mail following a predefined protocol.
Further follow up is planned every 2 to 3 years by means of questionnaires and medical examination in an outpatient clinic.


Study documentation, questionnaires and promotion materials

 

Obstetric record

Maternal information: maternal (pre-pregnancy and pregnancy) morbidities
Delivery: type of delivery, type of anaesthesia (if any), birth weight, gestational age at birth, stillbirth (>= 22 weeks), child’s sex birth, length, birth head circumference, apgar score, congenital malformations, illnesses and diseases, early breastfeeding



Baseline questionnaire

Demographic data: parental citizenship, years in Italy (if foreign), place of birth of grandparents.
Social background: parental occupations, parental educational level, employment. Household composition and Housing, indoor and outdoor pollution: crowding (person/room), ownership, dimension, number of rooms, floor, presence of mould or moisture, availability of gas water heater, air conditioning, types of heating and cooking at home, air circulation, use of chemicals in the home, proximity to heavy traffic, pets.
Leisure and life style: maternal leisure and sport activity during the year before pregnancy, maternal pre-pregnancy smoking and alcohol use, special nutritional needs, use of salt.
Health: paternal and maternal (pre-pregnancy) weight and height, maternal type of delivery, breastfeeding, menarche age and menstrual cycle regularity, parental weight at birth, parental morbidities, in particular diabetes and allergies; parental sleep pattern.
Reproductive history: previous reproductive outcomes, infertility, previous children breastfeeding, weight and gender, gestational age.
Pregnancy: emotional aspects (on pregnancy and in the last month using the GHQ-12, gestational week at the first visit, number of ultrasounds check, antenatal diagnosis tests, other aspects (contact with pets, type of work, use of chemicals, sport activity, hours at open air, snore, active and passive smoking, alcohol use, diet); morbidities and drug use; hospital admission; vitamin supplementation; pregnancy weight gain.
Delivery: early breastfeeding, newborn sleep position.



6 months questionnaire

For each month of life (from birth to 6 months): weight and length, breastfeeding, weaning, hours of sleep, pacifier use, passive smoking.
From birth to six months: foods items with the month of introduction; morbidities and drugs; day nursery.
Last 24 hours: food items and quantity.



12 months questionnaire

Child growth: neurodevelopment assessment, weight and length. Child health: diseases, hospital admittance, emergency room visits, drugs administered, unintentional injuries.
Child care: day nursery, mother and father activities with child, number of hours at open air per month.
Family habits: television viewing, maternal and paternal smoking habit, child passive smoking exposure.
Child nutrition: breast feeding, semi-quantitative food frequency. Child sleep: questions from “brief screening questionnaire for infant sleep”. Socioeconomic position: maternal and paternal occupational changes from birth to the first birthday, family income.
Household composition and housing: changes over time.
Maternal mood: mother-to-infant attachment scale, general health questionnaire (12 items), positivity scale.



24 months questionnaire

Child growth: neurodevelopment assessment, weight and height. Child health: diseases, hospital admittance, emergency room visits, drugs administered, unintentional injuries.
Child care: day nursery, mother and father activities with child. Child activities.
Family life style: maternal and paternal smoking habit, child passive smoking exposure.
Child nutrition: breast feeding, dietary patterns and feeding style. Child sleep: questions from “brief screening questionnaire for infant sleep”. Socioeconomic position: maternal and paternal occupational changes from the last follow-up.
Household composition and housing: changes over time.