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Public health
Protocol
Three contaminated sites in southern Italy. The Neonatal Environment and Health Outcomes cohort: protocol for a longitudinal birth cohort study
  1. Silvia Ruggieri1,
  2. Gaspare Drago1,
  3. Paolo Colombo1,
  4. Alessio Alesci1,2,
  5. Pasquale Augello1,3,
  6. Alessandro Bisbano4,
  7. Antonino Bucolo3,
  8. Patrizia Dattoli4,
  9. Raffaella De Sole4,
  10. Valentina La Runa1,5,
  11. Angela Lopez4,
  12. Lucia Lo Presti5,
  13. Bruno Magliarditi2,
  14. Francesco Paravati4,
  15. Giuseppe Pirillo4,
  16. Antonino Ziino Colanino6,
  17. Fabio Cibella1
  1. 1 National Research Council of Italy, Institute of Biomedicine and Molecular Immunology, Palermo, Italy
  2. 2 P.O. ’Fogliani', Local Health Authority (ASP) of Messina, Milazzo (ME), Italy
  3. 3 P.O. ’Umberto I', Local Health Authority (ASP) of Siracusa, Siracusa, Italy
  4. 4 P.O. ’San Giovanni di Dio', Local Health Authority (ASP) of Crotone, Crotone, Italy
  5. 5 P.O. di Lentini, Local Health Authority (ASP) of Siracusa, Lentini (SR), Italy
  6. 6 ASP Siracusa, Local Health Authority (ASP) of Siracusa, Siracusa, Italy
  1. Correspondence to Dr Fabio Cibella; fabio.cibella{at}ibim.cnr.it

Abstract

Introduction Exposure to environmental contaminants during pregnancy is one of the determinants of child’s future health outcomes. The effect of environmental pollution on pregnant women living in heavily polluted areas is of special interest and, in this context, the Neonatal Environment and Health Outcomes (NEHO) cohort will focus on the investigation of (1) toxicants transferred from the environment to the mother and from the mother to the developing fetus and (2) the influence of toxicants on pregnancy outcomes, fetal development and health status during infancy. Because the human placenta is positioned at the interface between the maternal/external environment and the embryo, it can be considered a highly informative matrix regarding many key pregnancy events that can shape infant’s future health.

Methods and analysis The NEHO cohort will enrol an estimated total of 800 pregnant women in three selected National Priority Contaminated Sites in southern Italy. Epidemiological data, concerning maternal health status, lifestyle and pregnancy, are obtained through questionnaires provided to the mother starting from the last 2 months of pregnancy. At delivery, maternal blood, umbilical cord blood and placenta tissue are collected to assess contaminant levels and to clarify how toxicants interact with the placental domain. Furthermore, placental transcriptome is studied in order to explore the interferences of toxicants on the role of the placenta in maternal/fetal interplay. Regular follow-up is planned at 6, 12 and 24 months.

Ethics and dissemination The study has been approved by all the Ethics Committees of the three National Priority Contaminated Sites involved: the Ethics Committee of the University Hospitals of Messina (18 September 2017, n. 9/2017); the Ethics Committee ‘Catania 2’ (11 July 2017, n. 38/2017/CECT2); the Ethics Committee of the Region of Calabria (20 July 2017, n. 173). Findings will be disseminated in the scientific community and on a regional basis for appropriate policy actions.

  • birth cohort study
  • maternal exposure
  • fetal exposure
  • polluted areas
  • developmental origins of health and disease

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-029471

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    Footnotes

    • SR and GD contributed equally.

    • Contributors SR, GD, PC and FC made substantial contributions to the conceptualisation and design of the study and are involved in study monitoring. They drafted and critically revised the manuscript for its intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work. AA, PA, ABi, ABu, PD, RDS, VLR, AL, LLP, BM, FP, GP and AZC made substantial contributions to data acquisition and were involved in drafting the manuscript. Each of the authors read and approved the final version of the manuscript.

    • Funding The CISAS project is a multidisciplinary project on environment/health relationships funded by the Italian Ministry of Education, Universities and Research (MIUR) and approved by the Interministerial Committee for Economic Planning (CIPE)—body of the Italian government—with Resolution no. 105/2015 of 23 December 2015.

    • Competing interests None declared.

    • Ethics approval The NEHO study protocol has been approved by the Ethics Committees responsible for the three involved NPCSs: the Ethics Committee of the University Hospitals of Messina for the NPCS of Milazzo-Valle del Mela (18 September 2017, n. 9/2017); the Ethics Committee ’Catania 2' for the NPCS of Augusta-Priolo (11 July 2017, n. 38/2017/CECT2); the Ethics Committee of the Region of Calabria for the NPCS of Crotone (20 July 2017, n. 173). Each participant read the information sheet and signed the informed consent. Copies of participants’ information sheets are available at the website (www.neho.it).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.

    • Map disclaimer The depiction of boundaries on the map(s) in this article do not imply the expression of any opinion whatsoever on the part of BMJ (or any member of its group) concerning the legal status of any country, territory, jurisdiction or area or of its authorities. The map(s) are provided without any warranty of any kind, either express or implied.