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bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. Downloaded from BMJ Paediatrics Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Paediatrics Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay- per-view fees (http://bmjpaedsopen.bmj.com). If you have any questions on BMJ Paediatrics Open’s open peer review process please email [email protected] http://bmjpaedsopen.bmj.com/ on September 25, 2021 by guest. Protected copyright. BMJ Paediatrics Open bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. Downloaded from Confidential: For Review Only Examining the effects of excess pre-pregnancy weight and gestational weight gain on allergic disease development in offspring: a protocol for a population-based study using health administrative databases in Ontario, Canada Journal: BMJ Paediatrics Open Manuscript ID bmjpo-2020-000893 Article Type: Protocol Date Submitted by the 29-Sep-2020 Author: Complete List of Authors: Srugo, Sebastian; University of Ottawa, School of Epidemiology and Public Health Gaudet, Laura; Queen's University, Department of Obstetrics and Gynecology; Kingston Health Sciences Centre, Department of Obstetrics and Gynecology Corsi, Daniel; Ottawa Hospital Research Institute, OMNI Research Group; University of Ottawa, School of Epidemiology and Public Health http://bmjpaedsopen.bmj.com/ Fakhraei, Romina; Ottawa Hospital Research Institute, OMNI Research Group; Children's Hospital of Eastern Ontario Research Institute Guo, Yanfang; Better Outcomes Registry and Network; University of Ottawa, School of Epidemiology and Public Health Fell, Deshayne B.; University of Ottawa, School of Epidemiology and Public Health; Children's Hospital of Eastern Ontario Research Institute Keywords: Epidemiology, Obesity, Pathology on September 25, 2021 by guest. Protected copyright. https://mc.manuscriptcentral.com/bmjpo Page 1 of 91 BMJ Paediatrics Open 1 2 3 4 bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. 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Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmjpo BMJ Paediatrics Open Page 2 of 91 bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. Downloaded from Running head: MATERNAL WEIGHT AND PEDIATRIC ALLERGIC DISEASE 1 2 3 TITLE 4 5 Examining the effects of excess pre-pregnancy weight and gestational weight gain on allergic disease 6 development in offspring: a protocol for a population-based study using health administrative databases in 7 8 Ontario, Canada 9 10 Confidential: For Review Only 11 AUTHORS 12 1 1,2,3,4 1,2,5,7 2,5 1,2,5,7 13 Sebastian A. Srugo, Laura Gaudet, Daniel Corsi, Romina Fakhraei, Yanfang Guo, and 14 Deshayne B. Fell1,5,6* 15 16 17 1School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada; 18 19 [email protected] (S.A.S.) 20 2 21 OMNI Research Group, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada; 22 [email protected] (D.C.) 23 24 3Department of Obstetrics and Gynecology, Queen’s University, Kingston, ON, Canada; 25 [email protected] (L.G.) 26 27 4Department of Obstetrics and Gynecology, Kingston Health Sciences Center, Kingston, ON, Canada 28 5Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada; [email protected] 29 30 (R.F.) http://bmjpaedsopen.bmj.com/ 31 6 32 ICES, Ottawa, ON, Canada 33 7Better Outcomes Registry & Network Ontario, Ottawa, ON, Canada; [email protected] (Y.G.) 34 35 36 *Correspondence to: Dr. Deshayne Fell, Children’s Hospital of Eastern Ontario Research Institute, Centre 37 38 for Practice Changing Research Building, Room L-1154, 401 Smyth Road, Ottawa, ON K1H 8L1, 39 40 Canada; Email: [email protected]; Telephone: +1 613-737-7600 Ext. 6033 on September 25, 2021 by guest. Protected copyright. 41 42 43 Abstract word count: 334 44 Body word count: 2247 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmjpo Page 3 of 91 BMJ Paediatrics Open bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. Downloaded from MATERNAL WEIGHT AND PEDIATRIC ALLERGIC DISEASE 1 2 3 ABSTRACT 4 5 Introduction 6 Over the last 20 years, excess maternal pre-pregnancy weight (overweight and obesity) and gestational 7 8 weight gain have become the most common morbidities in pregnancy. These morbidities may pose a 9 threat to fetal immunological development through associated metabolic dysfunction and inflammation 10 Confidential: For Review Only 11 and, as such, may partly explain the concurrent rise of pediatric allergic disease. We will examine the 12 13 effect of excess maternal pre-pregnancy weight and gestational weight gain during pregnancy on the 14 incidence of allergic diseases among offspring in Canada’s most populous province. 15 16 17 Methods and analysis 18 19 We will conduct a retrospective, population-based cohort study of all singleton live births to residents of 20 21 Ontario, Canada in 2012–13 and 2013–14. The study population will be defined using maternal-newborn 22 records from the provincial birth registry, which captures information on maternal pre-pregnancy weight 23 24 and gestational weight gain. The cohort will be linked with provincial health administrative databases, 25 allowing for follow-up of neonates through early childhood until 2019 (5–7 years of age). Allergic disease 26 27 development (asthma, rhinitis, atopic dermatitis, and anaphylaxis) will be ascertained using diagnostic 28 codes from healthcare encounters. Potential confounders have been identified a priori through a directed 29 30 acyclic graph. Cox proportional-hazards regression models will be employed to assess the associations http://bmjpaedsopen.bmj.com/ 31 32 between excess maternal pre-pregnancy weight, gestational weight gain, and incident pediatric allergic 33 disease. Several pre-planned sensitivity analyses will be conducted, including a probabilistic bias analysis 34 35 of outcome misclassification. 36 37 38 Ethics and dissemination 39 40 Ethics approval was obtained from the Research Ethics Board of the Children’s Hospital of Eastern on September 25, 2021 by guest. Protected copyright. 41 Ontario and the ICES Privacy Office. Findings will be disseminated in scientific conference presentations 42 43 and peer-reviewed publications. 44 45 46 Keywords: Pregnancy; Allergic disease; Pre-pregnancy weight; Gestational weight gain; Ontario 47 48 49 50 51 52 53 54 55 56 57 58 59 2 60 https://mc.manuscriptcentral.com/bmjpo BMJ Paediatrics Open Page 4 of 91 bmjpo: first published as 10.1136/bmjpo-2020-000893 on 5 January 2021. Downloaded from MATERNAL WEIGHT AND PEDIATRIC ALLERGIC DISEASE 1 2 3 ARTICLE SUMMARY 4 5 What is known on this subject 6 Excess maternal pre-pregnancy weight and gestational weight gain are common morbidities in 7 8 pregnancy and may impact fetal immunological development. 9 10 SeveralConfidential: studies have suggested these morbiditiesFor Reviewincrease the risk of asthma Only among offspring, 11 though their impact on other common allergic diseases is unclear.