ANZCTR search results

Improving surgical and pain relief techniques in laparocopic cholecystectomy has been exhaustively studied. However, in contrast to that, strongly contradicting evidence exists. This study seeks to examine if changes in surgical technique may be able to lessen the impact of surgery on health, by minimising the surgical insult and therefore facilitating an earlier discharge from hospital.

Parenteral nutrition (PN), consisting of carbohydrate, lipid, and amino acid constituent parts, is used in newborns when enteral feeding is insufficient. Those newborns requiring major surgery in the immediate postnatal period, comprising 17% of all late preterm and term newborns admitted to Australian NICUs per annum, are one such group with current supportive management emphasizing the importance of early nutrition. Recent data in children challenges this and suggests potential benefit from delayed provision of amino acids in the acute phase of a critical illness. The PEPaNIC (early vs late parenteral nutrition in the Paediatric ICU) RCT found that delaying PN (specifically amino acids) for a week following PICU admission reduced the length of admission by 30% and duration of ventilation by 40%, effects magnified on post-hoc analysis of the youngest patients. Confirmation of a similar response in ill surgical newborns is needed to drive practice change and improve both short- and longer-term clinical outcomes. Although the exact mechanism(s) remains unclear, the well newborn is exposed to a period of fasting for 48-72 hours following birth before the establishment of maternal milk supply, with fasting also a natural response to illness or surgical stress. Fasting results in up-regulation of autophagy which defines a phenotype of healing and repair, and which critically is suppressed by provision of amino acids. We hypothesize that delayed compared to early provision of the amino acid component of PN in late-preterm and term newborns requiring major surgery in the immediate neonatal period will shorten the duration of neonatal intensive care admission. The aim of this multi-centre, parallel group, superiority, blinded randomised controlled trial is to investigate the impact of delayed provision of the amino acid component of PN (intervention) versus early initiation (standard care) in late-preterm and term newborns requiring major surgery in the immediate newborn period on the duration of neonatal intensive care admission.

Cannabidiol (CBD) is a safe non-psychoactive compound in cannabis. It is available with a prescription under the special access scheme. It is available without prescription when approved at dosages less than 150mg. CBD (100mg) in coconut oil (1ml) will be administered to healthy volunteers (n=16) to determine it is present in the blood over time at safe and effective levels. Taking CBD with a fatty meal has been shown to increase blood concentrations. It is not known if taking it with coconut oil will produce a similar effect. The volunteers will receive CBD in coconut oil when fasting and on the second visit after a high-fat breakfast. The CBD (and its metabolites) levels will be monitored via blood collection and LC-MS/MS analysis using a previously validated method. It is expected the CBD levels will approach that of the high-fat group when administered with coconut oil.

Abdominal pain is a common reason for children to attend the Emergency Department (ED), with acute appendicitis is the most frequent cause of abdominal pain requiring surgical intervention with the highest incidence occurring in 10-to-20-year olds. Ruling in and ruling out the diagnosis of appendicitis is the main concern for acute care clinicians confronted with a child with abdominal pain with various clinical prediction scores (CPSs) developed to assist with diagnosing appendicitis. Most CPSs involve calculating a score based on combinations of different clinical features and laboratory findings to classify patients into low, intermediate, or high risk for appendicitis. The most frequently used scores in children are the Alvarado score, Pediatric Appendicitis Score, and the pediatric Appendicitis Risk Calculator. In addition, several other scores have been postulated in the literature with varying degrees of application and accuracy in children. However, CPSs have been inadequately validated and haphazardly adopted in Australia and New Zealand (ANZ), resulting in an increasing number of children undergoing unnecessary imaging and laboratory investigations compared to previous clinical practice. This project aims to address this issue by externally validating various commonly used CPSs in children aged 5 to <18 years presenting to ANZ EDs with acute abdominal pain with the suspicion of appendicitis and compare the CPSs’ performances against local clinician gestalt. This will improve accuracy of diagnosis, reduce healthcare costs, rationalise the use of healthcare resources, and improve management of childhood appendicitis. It will also provide a description of the current diagnostic and management approaches in ANZ for paediatric abdominal pain and appendicitis.

There is a lack of coordinated service provision for children and adolescents in NSW and Australia with functional and Chronic Tic Disorders, hindering efforts to systematically collect clinical data that can be translated into gold-standard practice and shape service development. Clinical expertise in Tic Disorders, including Tic Disorders, remains limited to tertiary centres and primary and secondary care clinicians report feeling ill-equipped in caring for young patients. Current service models cater poorly to young people with Tic Disorders (including Tourette Syndrome) where collaborative input in assessment and management planning is essential. The proposed Mindgardens FND Tic program (for children and adolescents with Tic Disorders) is a tertiary assessment and intervention program for children and adolescents providing multi-disciplinary assessment and a brief intervention program for suitable patients. This program will see participants referred by their GP or specialist with a diagnosis of a Tic Disorder including functional Tic Disorder, Chronic Tic Disorder, or Tourette Syndrome. Two different streams will form part of this research study. Such a program is not currently available in Australia in the public sector and is a significant gap in care provision for a group with high rates of physical and mental health (MH) morbidity, disability and healthcare utilisation Significance, Innovation & Benefit Given the increasing morbidity rates among children and adolescents with a diagnosis of Tic Disorders and the potential perceived stigma and poor mental health literacy for accessing the healthcare system, children and adolescents attending this program will benefit from the specialised intervention leading to positive health outcomes. Additionally, this pilot work will also help inform health service practice, planning, and policy, and improve resource allocation and capacity building.

The primary objective is to investigate the effects of peanut butter (43g/d), consumed for 6 months, on 1) older adults’ functional capacity (primary outcomes) and its associated factors such as cognitive function, lean mass, muscle strength, as well as late-life function and disability, which reflects real-world endpoint related to physical capacity. The secondary objective is to explore if the effects of peanut butter supplementation on primary objective outcomes are mediated by improvement in diet quality following peanut butter supplementation.

Premature babies (born before 8 months of pregnancy) are at risk necrotising enterocolitis (NEC), a potentially serious inflammatory condition of the bowel, as well as hospital acquired infections, and poor nutrition. Complications of prematurity such as these, especially NEC, increase the risk of death, and long-term disability. The risk of these complication is high especially in extremely premature babies born before 28 weeks of pregnancy. Probiotics are beneficial bacteria which have been shown to significantly reduce the risk of death, NEC, and hospital acquired infections whilst facilitating nutrition in very premature babies. Probiotic supplementation for very premature babies is a standard practice in all neonatal intensive care units (NICU) in Australia, New Zealand and many units in other countries. We currently administer a daily dose of 3 billion probiotic bacteria for premature babies in our unit using a product imported from Japan, under a special permission from the Australian government. This dose is based on our research using this product and studies of other probiotics. This study is designed to assess if a dose higher than 3 billion bacteria per day is more effective whilst being safe in reducing inflammation and improving the balance of beneficial versus potentially harmful bacteria in the gut of extremely premature babies. Specifically, the proposed study will compare the dose of 3 billion against 6 and 9 billion bacteria per day in extremely premature babies using the stool (poo) samples. We think that babies who receive higher dose of probiotics will have reduced gut inflammation, more beneficial and less harmful bacteria in the gut and overall health compared to those who receive lower dose.

Depression is highly prevalent and associated with increased hospitalisation and mortality among patients with heart disease. A whole-person care approach to depression management, encompassing mental wellbeing, behavioural risk factors and treatment adherence, is needed. This study will test whether a wellbeing program for patients discharged with Acute Decompensated Heart Failure (ADHF) improves emotional and physical wellbeing. A two-arm RCT with participants randomly allocated to intervention (an enhanced community care program for heart failure: “Enhanced HF Care”) or usual care. Eligible patients with ADHF will be recruited prior to discharge from two hospitals. Patients will be provided access to Enhanced HF Care, and via the program, will be prompted to monitor depression and clinical outcomes. Guideline adherent actions for clinically significant depression scores and clinical outcomes will be utilised. Automated parameters within Enhanced HF Care will trigger specific action advice for patients, such as self-care recommendations (via videos or written information). Cardiac nurse specialists will track real-time patient data from a dashboard, and receive automated emails when patients provide high-risk data. Cardiac nurses will prompt cardiologists to action, where needed. General practitioners will receive automated emails for patients reporting high levels of depression and encouraged to schedule a patient consultation. Outcomes will be assessed at one and six-months via brief measures for Quality of Life. Intervention participants will also complete brief weekly/fortnightly measures for depression via the program. Healthcare utilization will be examined via patient self-report and hospital admission data. The primary analysis population will be the intention to treat, defined as all randomised participants. The co-primary outcome variables will be compared between treatment arms using separate linear mixed effects regression models. This study has the potential to reduce the burden of depression for patients following ADHF. This novel process will prioritise urgent patient mental health needs while empowering the patient with self-care knowledge.

This study aims to determine whether the use of a herbal treatment (Annona muricata leaf product) is safe and tolerable for use in people with stage III and IV cancers of any type, who are not undergoing chemotherapy treatment. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any cancer type that is at stage III or stage IV, and you are not currently undergoing chemotherapy. Study details Participants who choose to enrol in this phase I study will be allocated to one of two doses of Annona muricata leaf product, and will be asked to take either one or two capsules daily for 12 weeks. At the time of enrolment, 3, 6, 9 and 12 weeks after their first dose, participants will be asked to provide a blood sample and to complete a series of questionnaires. It is anticipated that these tasks will take up to 30 minutes to complete, participants will be able to complete the questionnaire from home if they prefer. It is hoped this research will inform the clinical management and guidance provided by clinicians involved in the care of people who choose to use Annona muricata leaf product in the overall management of their cancer. If this product is found to be safe and tolerable, it may be prescribed to future cancer patients as an additional treatment.

We will recruit pregnant women with a prior history of gestational diabetes mellitus (GDM) as part of a randomised control trial (RCT) to undertake the healthy gut dietary intervention (or control). We hypothesise that women who are provided dietitian counselling and education about a Healthy Gut Diet will improve their gut health (measured as the gut microbiome) and be less likely to develop GDM. The primary outcome will the proportion of women developing GDM. Other outcomes include changes to gut microbiota, diet quality, gestational weight gain, and maternal and infant outcomes. The study sites are Redcliffe and Caboolture Hospitals.