ANZCTR search results

Most babies born preterm have breathing problems shortly after birth, and many need help with their breathing. Clinicians have many treatments to help preterm babies breath, and know which treatments works best for most babies. But clinicians don’t know which treatments will work best for each baby. The BLUEPRINT Study aims to provide a more precise picture (phenotype) of how a specific preterm baby’s lungs are working in the first 7 days after birth. This will be achieved by combining information on the clinical care being used, measurements of lung function and the pattern of proteins in the blood collected 3 and 7 days after birth. We will then follow babies through until 2 years of age to measure their lung growth and function. By understanding the different lung phenotypes that exist in preterm babies, we hope to help doctors know which treatments may be best for a baby and predict which baby might be at more risk for lung problems as they grow up.

This study aims to evaluate the implementation of an evidence-based, multi-component intervention that improves the metabolic health and wellbeing of Aboriginal and Torres Strait Islander women before, during and after a pregnancy complicated by diabetes. The intervention consists of co-designed strategies, informed by previous research. The implementation will continue to use participatory approaches (co-design), with participants monitoring progress and collaborating to enhance sustainability. The mixed-methods evaluation of the implementation will: a) Explore the impact of the multi-component intervention on the metabolic health and wellbeing of participants at the study sites; b) Explore the impact of the multi-component intervention on the study sites (communities/services) as health promoting environments; c) Determine the acceptability and sustainability of the multi-component intervention at the study sites; d) Identify the enablers and barriers to implementation of the multi-component intervention.

This is a Phase 1, first-in-human (FIH), randomised, double-blind, placebo controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-451 administered as an oral suspension in healthy participants.

This is a Phase 1 study to evaluate the effect of food on the PK of SION-451 and the bioequivalence of a tablet formulation compared with the oral suspension formulation in healthy participants.

This is a prospective study to assess signal parameters of the Bonsai Sensor across different builds or design iterations of the device. Up to 60 participants will be recruitment to achieve total of 300 nights of recordings for each sub-study. Participants with or without diagnosis of Obstructive Sleep Apnoea will be screened and enrolled.

This purpose of this study is to examine whether new brain training regimes (active interventions) can influence brain function and reduce persistent post-concussion symptoms. This study will compare two different types of brain training to the “standard treatment”, which for mTBI is no treatment other than symptom management (control with no intervention). This will aid in determining whether people in the brain training groups have less symptoms because of brain training, or whether they would have had a reduction in symptoms anyway during that time.

Researchers at the Australian Stuttering Research Centre have developed an online speech treatment program—iCamperdown—for adults who stutter. iCamperdown is an online version of the Camperdown Program, an evidence-based treatment for adults who stutter. iCamperdown is designed to teach adults who stutter a way to learn to control their stuttering without seeing a speech pathologist. The purpose of this study is to assess the safety of the iCamperdown Program, to evaluate compliance and preliminary treatment outcomes.

Ageing is associated with poor sleep which can contribute to cognitive decline. Non-invasive low current brain stimulation has been used as a method to enhance deep sleep in healthy adults and in some cases improve memory performance. However, intervention outcomes on sleep and memory were inconclusive across the different studies. This proof-of-concept study uses a new technique of brain stimulation which can target more specific brain areas compared to previous methods. This proof-of-concept study aims to evaluate the feasibility of applying high-definition slow oscillatory transcranial direct current stimulation (so-tDCS) in two brain regions – frontal and parietal, and assess the effects on slow oscillation activity during sleep in a middle to late aged healthy population. Participants will attend three in-person visits at the Woolcock Institute of Medical Research where they will receive low current brain stimulation during a nap. Participants will also complete cognitive tasks before and after the nap.

Head and neck lymphoedema (HNL) is a chronic swelling (‘oedema’) that often forms following cancer treatment of the head and neck. People with HNL often experience difficulty breathing, speaking and swallowing along with impaired movement and increased psychological distress and reduced quality of life. Treatment for HNL is inconsistent due to a low level of evidence, no recommended standard of care guidelines and poor assessment protocols leading to the condition being under-diagnosed and under-treated. This parallel, pilot-randomised control trial will evaluate the safety, feasibility and indication of effectiveness of adding early compression garment wear to standard care through random assignment of compression garments to participants 1-2 weeks following hospital discharge from neck dissection surgery. Who is it for? You may be eligible for this study if you are aged 18 years and over, planned to undergo cancer-related neck dissection surgery at Fiona Stanley Hospital (FSH), with no history or presence of external HNL at baseline (assessed at time of recruitment), have not previously had neck dissection surgery, have not previously received radiation therapy to the head or neck, are not receiving treatment for another cancer or have no known cognitive impairment. Study details Participants will be randomised to either the experimental group or the control group. Participants in the control group will receive standard treatment and telephone consultation, while participants in the experimental groups will receive 2 head and neck compression garments, standard treatment and video consultations. Safety outcomes include incidence of adverse events. Feasibility outcomes include recruitment data, participant perception of acceptability of the use of compression garments and adherence data. Participants are asked to keep an e-diary to record how frequently they wear the compression garment and complete standard home care. Indication of effectiveness will be evaluated using lymphoedema incidence and severity, symptom severity, quality of life, anatomical changes and range of motion outcomes. It is hoped that the findings from this study will develop an understanding on the safety, feasibility and effectiveness of adding early compression garment wear to standard care to inform future research.

The primary objective is to evaluate the feasibility of an Internet-delivered psychology pain self-management program, the Youth Pain Course (YPC), for Australian adolescents with chronic pain. This will be achieved through the following aims: 1. Assessing the acceptability of the YPC, via levels of treatment engagement, adherence, and adolescent- and carer-reported treatment satisfaction. 2. Determining the potential efficacy of the YPC on improving disability, pain severity and emotional functioning, post-treatment and at 6-months follow-up. 3. Exploring the demographic and clinical moderators (predictors) of treatment feasibility, including acceptability, efficacy, and costs. 4. Completing a preliminary cost-consequence analysis examining the costs of the treatment to providers, adolescents, and their carers, in relation to a range of potential economic outcomes.