Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the 'D-Kids' study protocol.

INTRODUCTION: Globally, acute respiratory infections (ARIs) are a leading cause of childhood morbidity and mortality. While ARI-related mortality is low in Australia, First Nations infants are hospitalised with ARIs up to nine times more often than their non-First Nations counterparts. The gap is widest in the Northern Territory (NT) where rates of both acute and chronic respiratory infection are among the highest reported in the world. Vitamin D deficiency is common among NT First Nations neonates and associated with an increased risk of ARI hospitalisation. We hypothesise that perinatal vitamin D supplementation will reduce the risk of ARI in the first year of life. METHODS AND ANALYSIS: 'D-Kids' is a parallel (1:1), double-blind (allocation concealed), randomised placebo-controlled trial conducted among NT First Nations mother-infant pairs. Pregnant women and their babies (n=314) receive either vitamin D or placebo. Women receive 14 000 IU/week or placebo from 28 to 34 weeks gestation until birth and babies receive 4200 IU/week or placebo from birth until age 4 months. The primary outcome is the incidence of ARI episodes receiving medical attention in the first year of life. Secondary outcomes include circulating vitamin D level and nasal pathogen prevalence. Tertiary outcomes include infant immune cell phenotypes and challenge responses. Blood, nasal swabs, breast milk and saliva are collected longitudinally across four study visits: enrolment, birth, infant age 4 and 12 months. The sample size provides 90% power to detect a 27.5% relative reduction in new ARI episodes between groups. ETHICS AND DISSEMINATION: This trial is approved by the NT Human Research Ethics Committee (2018-3160). Study outcomes will be disseminated to participant families, communities, local policy-makers, the broader research and clinical community via written and oral reports, education workshops, peer-reviewed journals, national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12618001174279.

The socioemotional challenges and consequences for caregivers of Aboriginal and Torres Strait Islander children with otitis media: A qualitative study.

INTRODUCTION: Living with ear disease can have extensive impacts on physical, emotional and social well-being. This study explored otitis media (OM) and its management from the perspective of caregivers of Aboriginal and Torres Strait Islander children. METHODS: Semi-structured interviews were conducted from 2015 to 2020 with caregivers of Aboriginal and Torres Strait Islander children with OM. Thematic analysis of transcripts was undertaken using a constructivist grounded theory approach through the leadership and the cultural lens of an Aboriginal community-based researcher. RESULTS: Caregivers described OM as having profound impacts on their child's physical, developmental, and emotional well-being, with long waits for specialist treatment contributing to extra strain on families. Children's well-being suffered when OM was mistaken for poor behaviour and children were punished, with caregivers subsequently experiencing strong feelings of guilt. Concerns were conveyed about the social implications of having a sick child. The variable nature of OM symptoms meant that caregivers had to monitor closely for sequelae and advocate for appropriate treatment. Success in navigating the diagnosis and treatment of OM can be strongly impacted by the relationship between caregivers and health professionals and the perceived access to respectful, collaborative and informative healthcare. CONCLUSION: OM may have substantial social and emotional consequences for children and their caregivers. A holistic understanding of the way in which OM impacts multiple facets of health and well-being, as well as recognition of challenges in accessing proper care and treatment, will aid families managing OM and its sequelae. PATIENT OR PUBLIC CONTRIBUTION: Governing boards, managers, staff and community members from five Australian Aboriginal Medical Services were involved in the approval, management and conduct of this study and the wider clinical trials. The caregivers of Aboriginal and Torres Strait Islander patients at these services informed the interview study and guided its purpose.

Stores Healthy Options Project in Remote Indigenous Communities (SHOP@RIC): a protocol of a randomised trial promoting healthy food and beverage purchases through price discounts and in-store nutrition education.

BACKGROUND: Indigenous Australians suffer a disproportionate burden of preventable chronic disease compared to their non-Indigenous counterparts--much of it diet-related. Increasing fruit and vegetable intakes and reducing sugar-sweetened soft-drink consumption can reduce the risk of preventable chronic disease. There is evidence from some general population studies that subsidising healthier foods can modify dietary behaviour. There is little such evidence relating specifically to socio-economically disadvantaged populations, even though dietary behaviour in such populations is arguably more likely to be susceptible to such interventions.This study aims to assess the impact and cost-effectiveness of a price discount intervention with or without an in-store nutrition education intervention on purchases of fruit, vegetables, water and diet soft-drinks among remote Indigenous communities. METHODS/DESIGN: We will utilise a randomised multiple baseline (stepped wedge) design involving 20 communities in remote Indigenous Australia. The study will be conducted in partnership with two store associations and twenty Indigenous store boards. Communities will be randomised to either i) a 20% price discount on fruit, vegetables, water and diet soft-drinks; or ii) a combined price discount and in-store nutrition education strategy. These interventions will be initiated, at one of five possible time-points, spaced two-months apart. Weekly point-of-sale data will be collected from each community store before, during, and for six months after the six-month intervention period to measure impact on purchasing of discounted food and drinks. Data on physical, social and economic factors influencing weekly store sales will be collected in order to identify important covariates. Intervention fidelity and mediators of behaviour change will also be assessed. DISCUSSION: This study will provide original evidence on the effectiveness and cost-effectiveness of price discounts with or without an in-store nutrition education intervention on food and drink purchasing among a socio-economically disadvantaged population in a real-life setting. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613000694718.

WITHDRAWN: Antibiotics for persistent nasal discharge (rhinosinusitis) in children.

BACKGROUND: Nasal discharge (rhinosinusitis) is extremely common in children. It is the result of inflammation of the mucosa of the upper respiratory tract, and is usually due to either infection or allergy. Infections may be caused by bacteria. OBJECTIVES: To determine the effectiveness of antibiotics versus placebo or standard therapy in treating children with persistent nasal discharge (rhinosinusitis) for at least 10 days. SEARCH STRATEGY: In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2005) which includes the ARI Group's specialised trials register; MEDLINE (1966 to April Week 3, 2005) EMBASE (1997 to December 2004), and the references of relevant articles were searched. Authors and pharmaceutical companies were contacted. SELECTION CRITERIA: All randomised controlled trials that compared antibiotics versus placebo or standard therapy. Trials which included the use of other medications were included if all participants were allowed equal access to such medications or if the additional or alternative therapies were regarded as ineffective. Trials that only combined or compared antibiotics with surgery, or sinus puncture and lavage, were not included in the review. DATA COLLECTION AND ANALYSIS: Data were extracted by a single author for the following eight outcomes: overall clinical failure (primary outcome), failure to cure, failure to improve, clinical improvement, time to resolution, complications, side-effects and bacteriologic failure. For the dichotomous outcome variables of each individual study, proportional and absolute risk reductions were calculated using a modified intention-to-treat analysis. The summary weighted risk ratio and 95% confidence interval (CI) (fixed effect model) were calculated using the inverse of the variance of each study result for weighting (Cochrane statistical package, RevMan version 4.2). MAIN RESULTS: A total of six studies involving 562 children compared antibiotics with placebo or standard therapy. All studies were randomised but most were still susceptible to bias. Five of the studies were conducted in emergency, allergy or ENT clinics. Four of the studies required children to have x-ray changes consistent with sinusitis. Only the primary outcome (overall clinical failure) was reported in all studies. Around 40% of all randomised children did not have a clinical success documented when reviewed two to six weeks after randomisation. The control event rate varied from to 22 to 71% (mean 46%). The risk ratio estimated using a fixed effects model was 0.75 (95% CI 0.61 to 0.92). There was no evidence of statistical heterogeneity. Side effects (sufficient to cease treatment) occurred in 4 of 189 control group children (four studies). More children treated with antibiotics had side effects (17 of 330), but this difference was not statistically significant (RR 1.75, 95% CI 0.63 to 4.82). AUTHORS' CONCLUSIONS: For children with persistent nasal discharge or older children with radiographically confirmed sinusitis, the available evidence suggests that antibiotics will reduce the probability of persistence in the short to medium-term. The benefits appear to be modest and around eight children must be treated in order to achieve one additional cure (number needed to treat (NNT) 8, 95% CI 5 to 29). No long term benefits have been documented. These conclusions are based on a small number of small randomised controlled trials and may require revision as additional data become available.