Maternal diet has the potential to affect human milk (HM) composition, but very few studies have directly assessed the effect of maternal diets on HM composition. The primary aim of this study was to assess the effect of improving dietary quality in lactating women over 2 weeks on the concentrations of macronutrients and metabolic hormones in HM. The secondary aims were to assess the impact of the dietary intervention on 24 h milk production, maternal body composition and infant growth. Fifteen women completed a 1-week baseline period followed by a 2-week dietary intervention phase targeted towards reducing fat and sugar intake. Maternal anthropometric and body composition and infant growth measurements were performed weekly. Total 24 h milk production was measured before and after the dietary intervention, and HM samples were collected daily. Maternal intakes of energy (−33%), carbohydrate (−22%), sugar (−29%), fat (−54%) and saturated fat (−63%) were significantly reduced during the dietary intervention. HM insulin, leptin and adiponectin concentrations were 10–25% lower at the end of the dietary intervention, but HM concentrations of macronutrients were unaffected. Maternal body weight (−1.8%) and fat mass (−6.3%) were significantly reduced at the end of the dietary intervention, but there were no effects on 24 h milk production or infant growth. These results suggest that reducing maternal energy, carbohydrate, fat and sugar intake over a 2-week period is associated with significant reductions in HM insulin, leptin and adiponectin concentrations. These changes may be secondary to decreases in maternal weight and fat mass. The limited studies to date that have investigated the association between metabolic hormone concentrations in HM and infant growth raise the possibility that the changes in HM composition observed in the current study could impact infant growth and adiposity, but further studies are required to confirm this hypothesis.

The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity, and cross-protection of different booster vaccination strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants, specific for the Australian context. The PICOBOO trial randomises participants to receive one of three COVID-19 booster vaccine brands (Pfizer, Moderna, Novavax) available for use in Australia, where the vaccine brand subtypes vary over time according to the national vaccine roll out strategy, and employs a Bayesian hierarchical modelling approach to efficiently borrow information across consecutive booster doses, age groups and vaccine brand subtypes. Here, we briefly describe the PICOBOO trial structure and report the statistical considerations for the estimands, statistical models and decision making for trial adaptations. This paper should be read in conjunction with the PICOBOO Core Protocol and PICOBOO Sub-Study Protocol 1: Booster Vaccination. PICOBOO was registered on 10 February 2022 with the Australian and New Zealand Clinical Trials Registry ACTRN12622000238774.

Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023. Online surveys were sent via AusVaxSafety, Australia’s active vaccine safety surveillance system, three and eight days after vaccination. A total of 131,775 day 3 surveys were sent, with a response rate of 38.5% (N = 50,721). A total of 43,875 day 8 surveys matched with day 3 survey responses were sent, with a response rate of 71.5% (N = 31,355). Half (50.7%) of respondents reported any adverse event following immunisation (AEFI) in the 0–3 days after vaccination and 24.6% reported any AEFI 4–7 days after vaccination. Fatigue, local pain, headache, and myalgia were the most frequently reported symptoms for both vaccines in both periods. After adjusting for respondent characteristics, vaccination clinic type, jurisdiction, and medical conditions, the odds for reporting AEFI increased with age from 16–19 years to highest odds at 30–39 years, after which it declined. Females had greater odd of reporting AEFI than males across most age groups, vaccine types, and doses. Respondents with a history of anaphylaxis had greater odds of reporting any AEFI (adjusted OR range: 1.50–2.86). A total of 3.1% of respondents reported seeking medical review 0–3 days after vaccination. This study affirms the short-term safety of Spikevax and Nuvaxovid COVID-19 vaccine priming doses in a large sample in Australia.

Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years. This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C₁ transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease. If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.