Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial.

OBJECTIVE: To investigate the regular use of xylitol, compared with sorbitol, to prevent acute otitis media (AOM), upper respiratory tract infections (URTIs) and dental caries. DESIGN: Blinded randomised controlled trial with a 6-month study period. SETTING: Enrolment took place at 11 primary care practices in Ontario, Canada. PATIENTS: Children aged 1-5 years who did not use xylitol or sorbitol at enrolment. INTERVENTIONS: Children were randomly assigned to use a placebo syrup with sorbitol or xylitol syrup two times per day for 6 months. MAIN OUTCOME MEASURES: Primary outcome was the number of clinician-diagnosed AOM episodes over 6 months. Secondary outcomes were caregiver-reported URTIs and dental caries. RESULTS: Among the 250 randomised children, the mean (SD) age was 38±14 months and there were 124 girls (50%). There were three clinician-diagnosed AOM episodes in the 125 placebo group participants and six in the 125 xylitol group participants (OR 2.04; 95% CI 0.43, 12.92; p=0.50). There was no difference in number of caregiver-reported URTI episodes (rate ratio (RR) 0.88; 95% CI 0.70, 1.11) between the placebo (4.2 per participant over 6 months; 95% CI 3.6, 5.0) and xylitol (3.7; 95% CI 3.2, 4.4) groups. Dental caries were reported for four participants in the placebo group and two in the xylitol group (OR 0.42; 95% CI 0.04, 3.05; p=0.42). In a post-hoc analysis of URTIs during the COVID-19 pandemic, the rate among the 59 participants receiving placebo was 2.3 per participant over 6 months (95% CI 1.8, 3.0) and for the 55 receiving xylitol, 1.3 over 6 months (95% CI 0.92, 1.82; RR 0.56; 95% CI 0.36, 0.87). The most common adverse event was diarrhoea (28% with placebo; 34% with xylitol). CONCLUSIONS: Regular use of xylitol did not prevent AOM, URTIs or dental caries in a trial with limited statistical power. A post-hoc analysis indicated that URTIs were less common with xylitol exposure during the COVID-19 pandemic, but this finding could be spurious. TRIAL REGISTRATION NUMBER: NCT03055091.

Xylitol for the prevention of acute otitis media episodes in children aged 2-4 years: protocol for a pragmatic randomised controlled trial.

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.

The role of non-governmental organisations in the management of separated and unaccompanied children, following disasters in Iran.

BACKGROUND: Following disasters, separated and unaccompanied children are among the most vulnerable, therefore international organisations have formed guidelines regarding the management of these children. Guidelines include recommendations for identifying and registering children, tracing family members, reunification and arrangements for interim and durable care. There is a lack of experiential evidence on how these principles are put into practice at operational levels, and whether existing policies were useful. There is a particular lack of empirical evidence from the disaster prone country of Iran. The aim of this study was to describe the role of Non- Governmental Organisations (NGOs) in the management of separated and unaccompanied children, following disasters in Iran in order to plan for and provision of future disasters. FINDINGS: The Iranian Red Crescent Organisation, Committee Emdad Imam Khomeini (a national organisation unique to Iran that is protected by the government and supported by public contributions) and Behzisti (the government welfare organisation in Iran) are the main figures involved in the management of separated and unaccompanied children, following disasters in Iran. NGOs are rarely responsible for caring for unaccompanied children, however they provide valuable support including financial assistance, arrangement of educational and extra-curricular activities and psychosocial support. Following the initial chaos after the Bam earthquake, international guidelines on separated and unaccompanied children were largely followed. CONCLUSIONS: Systems for managing separated and unaccompanied children following disasters in Iran, involving NGOs, are emerging. However, most are yet to be formalised.