Search

Introduction: Xylitol (or 'birch sugar') is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries., Methods and Analysis: This study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2-4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions., Ethics and Dissemination: Ethics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael's Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers., Trial Registration Number: NCT03055091; Pre-results., Competing Interests: Competing interests: There are no competing interests. PP reports receiving the following grants unrelated to this study: a grant from Hospital for Sick Children Foundation during the conduct of the study; a grant from Canadian Institutes of Health Research (FRN # 115059) for an ongoing investigator initiated trial of iron deficiency in young children, for which Mead Johnson Nutrition provides non-financial support (Fer-In-Sol liquid iron supplement)., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The study aims to describe overall gestational weight gain among Canadian women and to assess demographic, socio-economic, maternal, and pregnancy-related characteristics of gestational weight gain including uncovering the predictors above or below the range recommended by Health Canada. This study proceeds as a secondary data analysis of the Maternity Experiences Survey targeting women aged ≥15 years who had singleton live births in the Canadian provinces and territories in 2005/2006. The outcome variable considered was gestational weight gain within and outside the recommended guidelines. Various factors including demographic, socio-economic, maternal, and pregnancy-related characteristics were considered using multivariate statistical techniques. Bootstrapping was performed to account for the complex sampling design. One-third of women gained within the recommended guideline (32.6%), 18.7% gained below, and 48.7% gained above the recommended guideline. More than half of overweight (67.6%) or obese women (60.0%) gained above the guideline, and women with lower socio-economic status were more likely to gain above the recommended range. Conversely, being an immigrant, multiparous, and having health problems during pregnancy were associated with less weight gain during pregnancy as well as higher odds of gaining insufficient weight to meet the minimal weight gain guideline. In Canada, almost half of the women gain above the recommended guideline for weight gain in pregnancy. The findings may be useful to design interventions that target those at risk of gaining outside of the recommended guidelines and to reduce outcomes associated with inadequate or excessive gestational weight gain.