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Open Access Study protocol

Piccolipiù, a multicenter birth cohort in Italy: protocol of the study

Sara Farchi1, Francesco Forastiere2, Liza Vecchi Brumatti3, Sabrina Alviti4, Antonio Arnofi4, Tommaso Bernardini5, Maura Bin3, Sonia Brescianini4, Valentina Colelli1, Rodolfo Cotichini124, Martina Culasso1, Paolo De Bartolo6, Laura Felice7, Valentina Fiano8, Alessandra Fioritto6, Alfio Frizzi9, Luigi Gagliardi7, Giulia Giorgi7, Chiara Grasso8, Francesca La Rosa5, Claudia Loganes3, Paola Lorusso2, Valentina Martini6, Franco Merletti8, Emanuela Medda4, Veronica Montelatici10, Isabella Mugelli9, Silvia Narduzzi2, Lorenza Nisticò4, Luana Penna4, Elisa Piscianz3, Carlo Piscicelli5, Giulia Poggesi10, Daniela Porta2, Antonella Ranieli10, Gherardo Rapisardi9, Assunta Rasulo8, Lorenzo Richiardi8, Franca Rusconi10, Laura Serino134, Maria Antonietta Stazi4, Virgilia Toccaceli4, Tullia Todros11, Veronica Tognin3, Morena Trevisan8, Erica Valencic3, Patrizia Volpi3, Valentina Ziroli2, Luca Ronfani3* and Domenico Di Lallo1

Author Affiliations

1 Laziosanità- Agenzia di Sanità Pubblica della Regione Lazio (Public Health Agency, Lazio Region, Italy), Rome, Italy

2 Dipartimento di Epidemiologia del SSR del Lazio-ASL RME, Rome, Italy

3 Institute for Maternal and Child Health – IRCCS “Burlo Garofolo”, Via dell’Istria 65/1, Trieste 34137, Italy

4 CNESPS - Istituto Superiore di Sanità, Rome, Italy

5 Ospedale Cristo Re dell’Istituto Figlie di Nostra Signora a Monte Calvario, Roma, Italy

6 Casa di Cura Città di Roma, Rome, Italy

7 Department of Woman and Child Health, Ospedale Versilia, Local Health Authority 12, Viareggio, Italy

8 Cancer Epidemiology Unit-CeRMS, Department of Medical Sciences, CPO-Piemonte, University of Turin, Turin, Italy

9 Santa Maria Annunziata Hospital, Bagno a Ripoli, Italy

10 Unit of Epidemiology, “Anna Meyer” Children’s University Hospital, Florence, Italy

11 Maternal-Fetal Medicine Unit, Department of Surgical Sciences, AO Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy

12 Institute of Clinical Physiology, National Research Council, Pisa, Italy

13 School of Specialization in Hygiene and Preventive Medicine, Tor Vergata University, Rome, Italy

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BMC Pediatrics 2014, 14:36  doi:10.1186/1471-2431-14-36

Published: 7 February 2014

Abstract

Background

The fetal and infant life are periods of rapid development, characterized by high susceptibility to exposures. Birth cohorts provide unique opportunities to study early-life exposures in association with child development and health, as well as, with longer follow-up, the early life origin of adult diseases. Piccolipiù is an Italian birth cohort recently set up to investigate the effects of environmental exposures, parental conditions and social factors acting during pre-natal and early post-natal life on infant and child health and development. We describe here its main characteristics.

Methods/design

Piccolipiù is a prospective cohort of expected 3000 newborns, who will be recruiting in six maternity units of five Italian cities (Florence, Rome, Trieste, Turin and Viareggio) since October 2011. Mothers are contacted during pregnancy or at delivery and are offered to participate in the study. Upon acceptance, their newborns are recruited at birth and followed up until at least 18 years of age. At recruitment, the mothers donate a blood sample and complete a baseline questionnaire. Umbilical cord blood, pieces of umbilical cord and heel blood spots are also collected. Postnatal follow-up currently occurs at 6, 12, and 24 months of age using on-line or postal self administered questionnaire; further questionnaires and medical examinations are envisaged. Questionnaires collect information on several factors, including mother’s and/or child’s environmental exposures, anthropometric measures, reproductive factors, diet, supplements, medical history, cognitive development, mental health and socioeconomic factors. Health promotion materials are also offered to parents.

Discussion

Piccolipiù will broaden our understanding of the contribution of early-life factors to infant and child health and development. Several hypotheses on the developmental origins of health can be tested or piloted using the data collected from the Piccolipiù cohort. By pooling these data with those collected by other existing birth cohorts it will be possible to validate previous findings and to study rare exposures and outcomes.

Keywords:
Birth cohort; Early-life exposure; Infant and child health and development