Recent studies have demonstrated a beneficial role of steroids in severe community-acquired pneumonia, severe COVID-19 infection and acute respiratory distress syndrome (ARDS) of diverse aetiology. This multicentre randomised controlled trial in severe scrub typhus pneumonitis and ARDS will compare the effects of 6 mg of dexamethasone once per day with placebo, in addition to standard treatment, on ventilator-free days (VFD), mortality and ventilatory requirement.

The study, involving six sites, will recruit 440 patients with severe scrub typhus pneumonitis or ARDS to concealed, block-randomised, site-specific assignment of dexamethasone or placebo for 4–7 days. The primary outcome will be VFD, defined as days alive and free of ventilation at 28 days. Secondary outcomes will include 28-day mortality, need and duration of ventilation, and treatment failure, defined as death, or escalation of respiratory support from simple devices (nasal cannula, mask) to non-invasive or invasive ventilation, or the use of open-labelled steroids for worsening shock. The study will also ascertain if antinuclear antibody (ANA) expression during the acute phase of illness will predict steroid responsiveness. Subgroup analyses will be conducted a priori on ANA expression and the need for ventilation. All analyses will be conducted on an intention-to-treat basis. The trial, which commenced in April 2025, would clarify the role of corticosteroids in scrub typhus pneumonitis.

The Institutional Review Board and Ethics Committee of the lead site, Christian Medical College, Vellore, India, has approved the study (IRB Min No 15920 (INTERVE) dated 22 November 2023). The remaining five sites have obtained approval from their respective ethics committees. Study results will be published in an international peer-reviewed journal.

CTRI/2024/12/077709. Registered 5 December 2024.

Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.

This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).

The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

While chronic kidney disease (CKD) is well characterised in adults, less is known about the prevalence of CKD in children and adolescents, where it is rare and associated with unique characteristics and implications for long-term health outcomes. This study protocol outlines a systematic review to assess the global prevalence of CKD in children and adolescents along with causes and associated risk factors. This is warranted to better characterise prevalence and to identify at-risk groups that would benefit from screening efforts. We will explore the risk and burden of CKD and its variations by sociodemographic characteristics (age group, race, sex/gender) and geographical regions (country, International Society of Nephrology region and income groups based on World Bank country classifications).

We will conduct a systematic review of studies reporting on the prevalence of CKD in children and adolescents following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 (PRISMA-P-2015) and the PRISMA 2020 methodological guidelines (PRISMA 2020). Searches will be undertaken in the following databases with the date range from 2000 to date: Ovid MEDLINE, Ovid Embase, CINAHL, Cochrane Library, ProQuest Dissertations & Theses Citation Index (via Clarivate), Web of Science Core Collection, Google Scholar and grey literature sites (registries, government reports) to identify studies that report on the prevalence of CKD in children and adolescents from ages 0 to 18. The primary outcome will be the global prevalence of CKD in children and adolescents. Secondary outcomes will include the causes of and risk factors for CKD, and examining differences and temporal trends in CKD prevalence across countries, geographical regions, income levels and sociodemographic characteristics.

No direct involvement with patient data will be used in this systematic review, as data will be obtained from previously published reports. Ethical approval is therefore not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.

CRD42024547467.