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Paediatrics
Protocol
Nutritional impact on Immunological maturation during Childhood in relation to the Environment (NICE): a prospective birth cohort in northern Sweden
  1. Malin Barman1,2,
  2. Fiona Murray3,
  3. Angelina I Bernardi4,
  4. Karin Broberg5,
  5. Sven Bölte6,
  6. Bill Hesselmar7,
  7. Bo Jacobsson2,
  8. Karin Jonsson1,
  9. Maria Kippler5,
  10. Hardis Rabe4,
  11. Alastair B Ross1,
  12. Fei Sjöberg4,
  13. Nicklas Strömberg8,
  14. Marie Vahter5,
  15. Agnes E Wold4,
  16. Ann-Sofie Sandberg1,
  17. Anna Sandin3,9
  1. 1 Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, Göteborg, Sweden
  2. 2 Department of Obstetrics and Gynaecology, University of Gothenburg, the Sahlgrenska Academy, Institute of Clinical Sciences, Göteborg, Sweden
  3. 3 Sunderby Research Unit, Region Norrbotten, Luleå, Sweden
  4. 4 Department of Infectious Diseases, University of Gothenburg, Institute of Biomedicine, the Sahlgrenska Academy, Göteborg, Sweden
  5. 5 Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
  6. 6 Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research; Department of Women’s and Children’s Health, Karolinska Institutet & Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden
  7. 7 Department of Paediatrics, University of Gothenburg, Institute of Clinical Sciences, Göteborg, Sweden
  8. 8 Department of Odontology/Cariology, Umeå University, Umeå, Sweden
  9. 9 Department of Clinical Sciences, Unit of Pediatrics, Umeå University, Umeå, Sweden
  1. Correspondence to Dr Malin Barman; malin.barman{at}chalmers.se

Abstract

Introduction Prenatal and neonatal environmental factors, such as nutrition, microbes and toxicants, may affect health throughout life. Many diseases, such as allergy and impaired child development, may be programmed already in utero or during early infancy. Birth cohorts are important tools to study associations between early life exposure and disease risk. Here, we describe the study protocol of the prospective birth cohort, ‘Nutritional impact on Immunological maturation during Childhood in relation to the Environment’ (NICE). The primary aim of the NICE cohort is to clarify the effect of key environmental exposures—diet, microbes and environmental toxicants—during pregnancy and early childhood, on the maturation of the infant’s immune system, including initiation of sensitisation and allergy as well as some secondary outcomes: infant growth, obesity, neurological development and oral health.

Methods and analysis The NICE cohort will recruit about 650 families during mid-pregnancy. The principal inclusion criterion will be planned birth at the Sunderby Hospital in the north of Sweden, during 2015–2018. Questionnaires data and biological samples will be collected at 10 time-points, from pregnancy until the children reach 4 years of age. Samples will be collected primarily from mothers and children, and from fathers. Biological samples include blood, urine, placenta, breast milk, meconium, faeces, saliva and hair. Information regarding allergic heredity, diet, socioeconomic status, lifestyle including smoking, siblings, pet ownership, etc will be collected using questionnaires. Sensitisation to common allergens will be assessed by skin prick testing and allergic disease will be diagnosed by a paediatrician at 1 and 4 years of age. At 4 years of age, the children will also be examined regarding growth, neurobehavioural and neurophysiological status and oral health.

Ethics and dissemination The NICE cohort has been approved by the Regional Ethical Review Board in Umeå, Sweden (2013/18-31M). Results will be disseminated through peer-reviewed journals and communicated on scientific conferences.

  • birth cohort
  • allergy
  • nutrition
  • microbiology
  • toxicants
  • immunology

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-2018-022013

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    Footnotes

    • Contributors AS, A-SS and AEW initiated the study and are responsible for the conception and design of the work. All authors have been involved in the design of the cohort and is involved in data analysis and interpretation. FM and AS are responsible for data collection. MB and AR drafted the first version of the manuscript. KB, KJ, MK, NS, MV, AEW, A-SS and AS was involved in writing different parts of the manuscript. AIB, SB, BH, BJ, HR and FS contributed to the critical revision of the manuscript. MB was responsible for finalising the last version of the manuscript. All authors read and approved the manuscript before submission.

    • Funding Funding has been received from the Swedish Research Council (VR) project no 521-2013-3154, Swedish Research Council for Health, Working Life and Welfare (FORTE) project no 2014-0923, the Västra Götaland Region RUN 612-0618-15, Åke Wibergs Stiftelse, Jane and Dan Olsson Foundation, the Research and Innovation Unit at Region Norrbotten and through a regional agreement between Umeå University and Västerbotten County Council in the field of Medicine, Odontology and Health (711251).

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The NICE cohort has been approved by the Regional Ethical Review Board in Umeå, Sweden (2013/18-31M).

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