ANZCTR search results

Standard red blood cell transfusion is almost unavoidable in very preterm newborns. This common therapy likely causes harm by inciting an inflammatory response in the recipient, a precursor to injury and end organ morbidity. This inflammatory signal can be ameliorated with use of washed red blood cells. Though currently available from Red Cross this washed product incurs additional manufacturing costs and has a shorter half-life. Our randomised controlled trial will determine if washed, allogeneic red cells reduces end organ morbidity in surviving, very preterm newborns resulting in life-long benefit and thereby defraying the additional costs of product manufacture.

SAHMRI Women and Kids are conducting a new survey (MILQ), that will follow mother-infant pairs across the first 12 months of life to find out how South Australian babies are being fed. We would like to find out what is helpful in initiating and continuing breastfeeding, as well as anything that could make breastfeeding difficult. We are also interested in the timing of complementary foods (such as solids and semi-solids) and the types of foods given to babies in their first year of life. The aim of the MILQ study is to understand how families are feeding their full term infants over the first 12 months of life, and what challenges they experience. We hope to use this information to inform the support services at South Australian hospitals and postnatal care providers. The information collected will also help us understand the current practices for the introduction of complementary feeding.

Patients with neuromuscular disease can have impaired airway clearance which may lead to respiratory deterioration and death. Physiotherapy is vital in assisting with airway clearance for this patient population. Recent studies have suggested the use of high-frequency chest wall oscillation (HFCWO), however, there is little physiological evidence to support its efficacy. This study will use electrical impedance tomography and lung ultrasound to assess pre and post-treatment lung volume changes for patients receiving standard chest physiotherapy and HFCWO.

In the midst of an unfolding global pandemic, there is a dearth of information about how COVID 19 infection affects neonates born to women with suspected or proven COVID 19. This study will contribute to an emerging and global body of information about COVID 19 in the perinatal period, enabling timely reporting and appropriate health service planning to ensure optimal outcomes for neonates, mothers and families. The aim of this project is to investigate the population health impacts of COVID -19 in mothers and their newborn infants cared for in tertiary and non-tertiary neonatal facilities. The research questions/hypothesis this study seeks to address include: 1. Incidence of COVID-19 in pregnant women and their newborn infants 2. Describe the outcomes for mothers and their newborn infants with COVID-19 3. Identify incidence of SARS-CoV-2 infection in the neonatal period and describe clinical course and outcomes for newborn infants with COVID-19 4. Collaborate with international COVID-19 registries to inform global variations and outcomes in care of newborn infants

The aims of this study are to evalute the uptake and acceptability of point fo care testing for hepatitis C using the Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, as compared to standard of care HCV testing in persons who inject drugs presenting to the medically supervised injecting room in Richmond, Victoria. We also seek to evaluate if point of care testing increases the rates of initiation of HCV treatment. Participants will be those persons over the age of 18 years who inject drugs that visit the medically supervised injecting room in Richmond, Victoria. The study will be a time series design, with two arms, conducted over ten months. The recruitment phase will be a total of four months, with each arm (standard of care, point of care) recruiting for a consecutive period of two months. Participants recruited in the first two months (months 1-2) will undergo standard of care testing for HCV. Participants recruited in the subsequent two months (months 3-4) will undergo point of care testing with Xpert HCV VL Fingerstick. Participants who return a positive HCV RNA result, suggestive of chronic hepatitis C infection, will be offered treatment with direct acting antiviral therapy. Participants will be followed up throughout the treatment course at four-weekly intervals, at end of treatment and at 12 weeks post treatment completion to assess for sustained virological response (SVR12). Participants will also complete questionnaires at enrolment, following HCV testing and at each follow up visit to assess acceptability of point of care testing, as compared to standard of care testing.

Reduction in subclinical inflammation is a potential target for chronic disease prevention, and pro-inflammatory effects of foods are observed following consumption of a single high fat meal. However, there is no consensus regarding inflammatory mediators that best characterise postprandial inflammatory responses. There are also few studies which account for the complex nutritional matrix that exists at mealtimes. Therefore, this study aims to identify whether plasma IL-6, IL-1ß, TNF-a and IL-10, the most commonly measured inflammatory mediators in postprandial research, are appropriate outcomes measures in postprandial protocols comparing acute inflammatory effects of mixed meals. In a randomised controlled, crossover design, 12 adults aged between 50 and 75 years, who are above a healthy weight, will consume three isocaloric (2.2 MJ) meals designed to have a low (-6.24), moderate (-2.76) or high (+9.36) Dietary Inflammatory Index (DII) score, after an overnight fast. Fasting and postprandial blood samples will be collected over five hours and analysed for plasma IL-6, IL-1ß, TNF-a and IL-10. Post-hoc power calculations will be used for future research, to identify appropriate outcome measures, that can be used to perform sample size calculations for larger fully-powered studies. To aid the interpretation of inflammatory responses, this study will also assess differences on postprandial glucose, insulin, lipids and subjective measures of appetite between the three test meals.

This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.

This clinical trial is to evaluate the PK, safety, tolerability and food effects of oral suspension and solid dosage formulations of PRAX-114 in healthy participants aged 18 to 55 years inclusive.

1. Background Urethral strictures are a common cause of urinary issues for men worldwide. Repair of the urethra with a tissue graft taken from inside the cheek is currently the best treatment for long urethral strictures. Whilst the use of an oral graft to repair urethral strictures is well studied, there has been less research into mouth problems (e.g. pain, infection) after the graft is taken. 2. Aims This study aims to determine the rate of post-operative mouth problems in men who had an oral graft taken from inside their cheek and used to repair their urethral stricture. This study will also investigate if certain patient's features (e.g. age, medical conditions) or operative details (e.g. size of oral graft, length of urethral stricture) are more likely to result in complications after the surgery. 3. Hypothesis Patients who have an oral graft surgically removed are at risk of developing mouth problems. Some patient features or operative details may increase the likelihood of complications.

The ESODICE trial is a Phase 2 open label randomised trial of drainage of pleural effusion in patients admitted to an intensive care unit. Coprimary endpoints are: a) safety, determined by rates of pleural effusion related serious adverse events at the earlier of 90 days or hospital discharge; b) efficacy, defined as statistically significant improvement in P:F ratio at 48 hours compared to randomisation.