ANZCTR search results

Vaxxas Pty Ltd is developing a novel needle-free high-density microarray patch (HD MAP) delivery system for the intradermal administration of vaccines. This technology may offer potential advantages over conventional needle and syringe delivery of vaccines. This Phase I clinical study is a critical step in the development of the HD-MAP delivery system to verify its safety and suitability for use in children. The study will help confirm the safety and consistency in performance of the HD-MAP delivery system in children at different anatomical administration sites and using different hold times. The paediatric population represents a significant segment of the population requiring vaccination; therefore, evaluating the safety and suitability of the HD-MAP delivery system in children is essential. The findings could support the future development of a needle-free approach to routine childhood vaccinations and facilitate vaccine delivery in low- and middle-income countries, including during outbreak scenarios.

Babies in neonatal intensive care often need peripheral intravenous (IV) lines, but fluid can leak from the vein into surrounding tissue and cause infiltration or extravasation injury. This study will assess whether the Vedette device can safely and continuously measure transcutaneous bioelectrical impedance near an IV site and collect signals of sufficient quality for future early-detection development. Up to 55 babies will have up to four neonatal ECG-style adhesive electrodes placed on the skin and connected to Vedette for 5 to 24 hours per day, without changing their usual treatment or replacing routine IV-site checks. The main outcomes are the frequency of electrode-related skin injury and the proportion of babies who provide at least one usable recording lasting five continuous hours. The study will also explore whether changes in the bioimpedance signal correspond with clinical events such as IV infiltration, swelling or IV-site changes.

This study will test whether a non-invasive ear sensor can help track body temperature more closely in adults with major burns who come to the Alfred Emergency and Trauma Centre. Currently, temperature is checked at set points using a forehead thermometer, or continuously through invasive probes inserted into the food pipe or bladder. The researchers expect that using this wearable, easy-to-apply ear sensor for continuous monitoring will pick up more episodes of temperature outside the recommended range, including hypothermia (low body temperature). Hypothermia is common in patients with large burns and has been associated with poorer outcomes. The aim of this interventional study is to measure these temperature episodes and to look at whether detecting them affects how patients are treated and how they recover, including their time in intensive care and hospital.

This project will develop and test a Queensland Transition Coaching Program to support young people aged 15–19 years with acquired brain injury (ABI) as they move from child to adult health and support services. The program will be co-designed with young people, families, clinicians and community services to ensure it reflects lived experience and meets the needs of Queenslanders. A pilot involving 60 participants from metropolitan and regional Queensland will focus on building confidence, independence and practical skills, including understanding ABI, self-advocacy, managing supports, navigating adult services and maintaining healthy lifestyles. Psychology support will be available to help young people engage with the program. Feedback from participants, families and clinicians will be used to assess whether the program is useful, accessible and appropriate, and to inform the development of a statewide ABI transition protocol, toolkit and training resources.

Preterm infants born <30 weeks’ gestation are at increased risk from additional damage to their already impaired lungs through Lower Respiratory Tract Infections over their first year of life. Data supports the use of trained immunity vaccines to reduce rates of Lower Respiratory Tract Infections and wheeze/asthma in the at risk populations, which include small numbers of preterm infants, not currently separately analyzed. This study aims to apply this potentially effective treatment specifically to a very preterm population. It is hypothesized that treatment with Bactek in the first year of life will reduce Lower Respiratory Tract Infections and Lower Respiratory Tract Infection associated healthcare utilization in infants born very preterm.

This study aims to test the accuracy of two types of biopsy methods that is being proposed to get bigger sample of the lymph gland tissue used during the procedure. The first is by putting a pair of forceps (Intranodal Forceps Biopsy) through the airpipes into the lymph gland and removing a sample and the second is to put a freezing probe (Mini-Cryobiopsy) thought the airpipes into the lymph gland and removing a sample. We will compare samples we get using these techniques with what we usually do which is using a needle. Who is it for? You may be eligible for this study if you are male or female aged 18 years and older who are scheduled to undergo an EBUS procedure to biopsy enlarged lymph nodes in the chest (mediastinal and/or hilar lymph nodes). Study details All those who are eligible will undergo a standard EBUS procedure under general anaesthesia. During the procedure, tissue samples will be collected from the target lymph node using three biopsy methods: standard needle biopsy (EBUS-TBNA), intranodal forceps biopsy (EBUS-IFB), and mini-cryobiopsy (EBUS-MCB). All participants will receive all three biopsy methods. The order in which the forceps biopsy and mini-cryobiopsy are performed will be determined by chance (randomisation). The procedure is expected to take approximately 45 to 60 minutes and will be performed in the endoscopy unit of participating Australian hospitals. The collected tissue samples will undergo a range of laboratory tests, including cytology, histopathology, immunohistochemistry, molecular profiling, and, where required, microbiological testing and flow cytometry. It is hoped that this research will identify the most effective biopsy approach for diagnosing conditions that cause enlarged chest lymph nodes, helping patients receive an accurate diagnosis and appropriate treatment while reducing the need for additional procedures.

This study investigates whether adding pulsed direct current (DC) electrical stimulation, delivered via the Neubie device, to a supervised exercise program produces greater improvements in walking ability, strength, and balance in adults with Multiple Sclerosis (MS) compared with exercise alone. Forty participants will be randomly allocated to either 8 weeks of combined DC stimulation and exercise, or exercise alone. Assessments will occur at baseline, mid-intervention, post-intervention, and at a 6-week follow-up to determine whether any improvements are maintained over time. Findings will inform whether this combined approach offers a practical and effective rehabilitation strategy for people with MS.

Brief description of the study purpose: The study aims to evaluate whether a brief online education module can help cares of people with cancer feel more confident communicating with healthcare providers, improve their health literacy, increase their preparedness for carefiving, and support their psychological wellbeing. Who is it for? You may be eligible for this study if you are 18 years or older who provide support for someone currently receiving treatment for cancer, where the cancer diagnosis was made within the past three years. Participants must be able to read and speak English and have access to the internet and a digital device. Study details All eligible participants will be randomly assigned to one of two groups. One group will complete a 15-minute online eLearning module designed to strengthen communication and advocacy skills when interacting with the healthcare providers. The module includes interactive activities and audio-visual educational content and can be completed at the participant's own pace. The other group will continue providing care as usual and will not receive the training during the study period. All participants will complete online questionnaires at the start of the study, 2 weeks later, and 3 months later. The survey will assess factors such as communication confidence, health literacy, caregiving preparedness, psychological wellbeing, and experiences interacting with healthcare providers. Participants in the control group will receive access to the eLearning module after completing the final survey, and will not be assessed for impact of the module. It is hoped that this research will help identify effective ways to support cancer carers, enabling them to communicate more confidently with healthcare providers and improve the quality of care and support provided to people affected by cancer.

The Let’s Grow+ trial is designed to assess the efficacy, cost-effectiveness, and scalability of a mobile health intervention aimed at improving nutrition, physical activity, sleep, and reducing sedentary behaviour in toddlers. The intervention involves a 6-month mHealth program delivered via an app, including behaviour change techniques like goal setting and self-monitoring, supported by push notifications.

People living with rheumatic fever and rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to deliver the antibiotic, called ‘SCIP’, which provides 10-weeks of protection. By partnering with Derbarl Yerrigan Health Service, we will offer SCIP to people in need of regular BPG in Perth, Western Australia, and evaluate how well it works for them, with the ultimate goal of using SCIP to reduce rheumatic heart disease morbidity. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.