Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.

<h4>Background</h4>The study of women exposures and child outcomes occurring in the first 1,000 days of life since conception enhances understanding of the relationships between environmental factors, epigenetic changes, and disease development, extending beyond childhood and spanning th...

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Main Authors: Leonardo Villani, Angelo Maria Pezzullo, Roberta Pastorino, Alessandra Maio, Francesca Stollagli, Chiara Tirone, Marta Barba, Angela Maria Cozzolino, Denise Pires Marafon, Martina Porcelli, Annamaria Sbordone, Maria Letizia Patti, Anthea Bottoni, Angela Paladini, Simona Fattore, Domenico Marco Romeo, Ornella Parolini, Wanda Lattanzi, Guido Rindi, Luca Tamagnone, Marco Marazza, Maurizio Genuardi, Elisabetta Tabolacci, Eugenio Maria Mercuri, Antonio Chiaretti, Tina Pasciuto, Maurizio Sanguinetti, Vincenzo Valentini, Giovanni Scambia, Walter Ricciardi, Giovanni Vento, Antonio Lanzone, Stefania Boccia
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0317458
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author Leonardo Villani
Angelo Maria Pezzullo
Roberta Pastorino
Alessandra Maio
Francesca Stollagli
Chiara Tirone
Marta Barba
Angela Maria Cozzolino
Denise Pires Marafon
Martina Porcelli
Annamaria Sbordone
Maria Letizia Patti
Anthea Bottoni
Angela Paladini
Simona Fattore
Domenico Marco Romeo
Ornella Parolini
Wanda Lattanzi
Guido Rindi
Luca Tamagnone
Marco Marazza
Maurizio Genuardi
Elisabetta Tabolacci
Eugenio Maria Mercuri
Antonio Chiaretti
Tina Pasciuto
Maurizio Sanguinetti
Vincenzo Valentini
Giovanni Scambia
Walter Ricciardi
Giovanni Vento
Antonio Lanzone
Stefania Boccia
author_facet Leonardo Villani
Angelo Maria Pezzullo
Roberta Pastorino
Alessandra Maio
Francesca Stollagli
Chiara Tirone
Marta Barba
Angela Maria Cozzolino
Denise Pires Marafon
Martina Porcelli
Annamaria Sbordone
Maria Letizia Patti
Anthea Bottoni
Angela Paladini
Simona Fattore
Domenico Marco Romeo
Ornella Parolini
Wanda Lattanzi
Guido Rindi
Luca Tamagnone
Marco Marazza
Maurizio Genuardi
Elisabetta Tabolacci
Eugenio Maria Mercuri
Antonio Chiaretti
Tina Pasciuto
Maurizio Sanguinetti
Vincenzo Valentini
Giovanni Scambia
Walter Ricciardi
Giovanni Vento
Antonio Lanzone
Stefania Boccia
author_sort Leonardo Villani
collection DOAJ
description <h4>Background</h4>The study of women exposures and child outcomes occurring in the first 1,000 days of life since conception enhances understanding of the relationships between environmental factors, epigenetic changes, and disease development, extending beyond childhood and spanning the entire lifespan. Generation Gemelli is a recently launched case-control study that enrolls mother-newborns pairs in one of the largest university hospitals in Italy, in order to examine the association between maternal environmental exposures and intrauterine growth restriction (IUGR) and the risk of premature birth. The study will also evaluate the association of maternal exposures and the health and growth of infants and children up to 24 months of age.<h4>Methods</h4>The study entails the set-up of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, we aim to enroll 140 cases (newborns with IUGR and premature birth) and 280 controls per year, from September 2022. A comprehensive questionnaire will be used to gather information about various types of maternal environmental exposures before and during pregnancy. We will collect biological samples from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. We will perform laboratory examinations including dosage of heavy metals and essential elements, investigation of placental distress and fetal brain damage of biomarkers, analysis of microbiota and of DNA methylation profile. We will conduct clinical follow-up assessments in both cases and controls at months 12 and 24 and we will collect anthropometric data, feeding types with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development.<h4>Discussion</h4>The Generation Gemelli case-control study holds the promise of significantly enhancing our comprehension of how maternal environmental exposures relate to the health of children and the broader population. The study of the exposome will provide insights into the relationships between environmental exposures, epigenetic changes and health outcomes during the first 1000 days of life and onward.
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spelling doaj-art-3fe3e83dc7f44f449f56ae7701cce4a32025-02-05T05:31:18ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01201e031745810.1371/journal.pone.0317458Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.Leonardo VillaniAngelo Maria PezzulloRoberta PastorinoAlessandra MaioFrancesca StollagliChiara TironeMarta BarbaAngela Maria CozzolinoDenise Pires MarafonMartina PorcelliAnnamaria SbordoneMaria Letizia PattiAnthea BottoniAngela PaladiniSimona FattoreDomenico Marco RomeoOrnella ParoliniWanda LattanziGuido RindiLuca TamagnoneMarco MarazzaMaurizio GenuardiElisabetta TabolacciEugenio Maria MercuriAntonio ChiarettiTina PasciutoMaurizio SanguinettiVincenzo ValentiniGiovanni ScambiaWalter RicciardiGiovanni VentoAntonio LanzoneStefania Boccia<h4>Background</h4>The study of women exposures and child outcomes occurring in the first 1,000 days of life since conception enhances understanding of the relationships between environmental factors, epigenetic changes, and disease development, extending beyond childhood and spanning the entire lifespan. Generation Gemelli is a recently launched case-control study that enrolls mother-newborns pairs in one of the largest university hospitals in Italy, in order to examine the association between maternal environmental exposures and intrauterine growth restriction (IUGR) and the risk of premature birth. The study will also evaluate the association of maternal exposures and the health and growth of infants and children up to 24 months of age.<h4>Methods</h4>The study entails the set-up of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, we aim to enroll 140 cases (newborns with IUGR and premature birth) and 280 controls per year, from September 2022. A comprehensive questionnaire will be used to gather information about various types of maternal environmental exposures before and during pregnancy. We will collect biological samples from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. We will perform laboratory examinations including dosage of heavy metals and essential elements, investigation of placental distress and fetal brain damage of biomarkers, analysis of microbiota and of DNA methylation profile. We will conduct clinical follow-up assessments in both cases and controls at months 12 and 24 and we will collect anthropometric data, feeding types with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development.<h4>Discussion</h4>The Generation Gemelli case-control study holds the promise of significantly enhancing our comprehension of how maternal environmental exposures relate to the health of children and the broader population. The study of the exposome will provide insights into the relationships between environmental exposures, epigenetic changes and health outcomes during the first 1000 days of life and onward.https://doi.org/10.1371/journal.pone.0317458
spellingShingle Leonardo Villani
Angelo Maria Pezzullo
Roberta Pastorino
Alessandra Maio
Francesca Stollagli
Chiara Tirone
Marta Barba
Angela Maria Cozzolino
Denise Pires Marafon
Martina Porcelli
Annamaria Sbordone
Maria Letizia Patti
Anthea Bottoni
Angela Paladini
Simona Fattore
Domenico Marco Romeo
Ornella Parolini
Wanda Lattanzi
Guido Rindi
Luca Tamagnone
Marco Marazza
Maurizio Genuardi
Elisabetta Tabolacci
Eugenio Maria Mercuri
Antonio Chiaretti
Tina Pasciuto
Maurizio Sanguinetti
Vincenzo Valentini
Giovanni Scambia
Walter Ricciardi
Giovanni Vento
Antonio Lanzone
Stefania Boccia
Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
PLoS ONE
title Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
title_full Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
title_fullStr Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
title_full_unstemmed Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
title_short Environmental maternal exposures and the risk of premature birth and intrauterine growth restriction: The Generation Gemelli study protocol of newborn exposome.
title_sort environmental maternal exposures and the risk of premature birth and intrauterine growth restriction the generation gemelli study protocol of newborn exposome
url https://doi.org/10.1371/journal.pone.0317458
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