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Pilot testing a model of Neonatal Nurse Controlled Analgesia (NNCA) to manage post-operative pain in the surgical neonate.
A model of neonatal nurse-controlled analgesia (NNCA) to manage neonatal surgical pain has been developed. This model was informed through the literature, the results of a systematic review, a survey of current Australasian neonatal pain practices and an expert panel of neonatal clinicians/researchers with knowledge/expertise of pain assessment and management practice across Australia and New Zealand. The final model of this NNCA will be tested in the Cardiac/surgical neonatal intensive care unit (C/S:NCCU) of the Mater Mothers’ Hospital South Brisbane. This pilot trial will be a randomised controlled trial to test the feasibility of study methodology. Infants will be randomised into either the control arm and receive current standard postoperative pain management or the intervention arm in which infants will receive postoperative pain management as per the model of NNCA.
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Evaluating uptake, engagement and effects of the Partners in Parenting (PiP) online parenting program, for adult carers of adolescents (12-18), delivered via headspace National Youth Mental Health Foundation.
This study aims to evaluate the uptake, engagement, and short-term effects of Partners in Parenting (PiP), an online parenting program, for adult carers of adolescents (aged 12-18) to support their adolescent’s mental health. The program aims to build carers’ parenting skills and confidence by equipping them with evidence-based parenting strategies that are associated with reduced risk and impact of depression and anxiety disorders in adolescents. The program is being delivered online, to adult carers of a young person (aged 12 to 18), who have an online account on the headspace National Youth Mental Health Foundation website (https://headspace.org.au/). The PiP program comprises up to 10 self-guided, online modules covering different topics related to parenting and adolescent mental health. Carers can also choose to complete a self-assessment survey to receive tailored feedback about their parenting, as well as feedback about their adolescent’s symptoms of anxiety and depression. In this trial, we aim to evaluate: 1) changes in parenting practices and parenting confidence, from pre- to post-program; 2) changes in adolescent symptoms of depression and anxiety, from pre- to post-program; 3) uptake of the program by adult carers via their headspace account, including factors that improve or reduce uptake; 4) engagement with the program (e.g. how much of the program is completed), including factors that may improve or reduce engagement; and 5) satisfaction and acceptability of the program by carers. We hypothesise that carers who complete the PiP program will report improved parenting skills and confidence 3-months after starting the program, as well as improved (reduced) symptoms of depression and anxiety in their adolescent child. Because the analysis of program uptake, engagement and acceptability is exploratory, no hypotheses have been specified.
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CLL08 - A study to evaluate the efficacy of venetoclax/rituximab (VenR) re-treatment in relapsed/refractory Chronic Lymphocytic Leukaemia (CLL) patients with disease progression following VenR as their last line of therapy.
The purpose of this study is to evaluate the efficacy of retreatment with Venetoclax and Rituximab in relapse and refractory CLL patients. Who is it for? You may be eligible for this study if you are aged 18 and above and have relapsed/refractory chronic lymphocytic leukaemia (CLL) with disease progression following two years of VenR therapy. Study details This study design involves two phases of study treatment: 1) VENETOCLAX RAMP UP: this phase will have two parallel cohorts that will receive the same treatment. -Cohort A: for patients with 12-24 months since last dose of Ven -Cohort B: for patients with greater than or equal to 24 months since last dose of Ven An initial dose of 20mg venetoclax is administered orally for all patients on day 1 - If a patient demonstrates one or more electrolyte abnormalities suggestive of laboratory TLS during the 24 hour period after the first dose: • Electrolyte abnormalities will be treated according to the Electrolyte Management Guidelines • Following resolution of electrolyte abnormalities, patients may be instructed to resume self-administration of venetoclax at 20mg daily for an additional 6 days. • Patients will then increase the venetoclax dose to 50mg daily and be monitored as described above. If the 50mg dose is tolerated without any abnormalities, daily dosing of venetoclax will continue at 50mg daily for a total of 7 days. • The venetoclax dose is then increased to 100mg daily for 1 week (week 3), followed by 200mg daily for 1 week (week 4) and then increased to 400mg daily (week 5). For patients who do not show any evidence of electrolyte abnormalities suggestive of laboratory TLS during the 24 hours after the initial 20mg dose: • Venetoclax will be escalated to 50mg on day 2 and patients will be monitored for TLS over 24 hours. • If the 50mg dose is tolerated, daily dosing of 50mg venetoclax will continue for a total of 6 days. • The venetoclax dose is then increased to 100mg daily for 1 week (week 2), followed by 200mg daily for 1 week (week 3) and then increased to 400mg daily (week 4). 2) VENETOCLAX IN COMBINATION WITH RITUXIMAB - After the patient has completed the venetoclax ramp-up period and received the target dose of 400 mg of venetoclax for 1 week with no evidence of laboratory or clinical TLS, the patient will begin combination therapy consisting of 6 cycles of rituximab (infusions occurring on Day 1 of each 28-day cycle) in combination with the 400mg daily dose of venetoclax. -Rituximab will be administered to patients in both treatment arms at 375 mg/m2 IV on Day 1 of Cycle 1 followed by 500 mg/m2 on Day 1 of Cycles 2 through 6 (total of six infusions of rituximab). It is hoped this research will determine if patients with relapsed/refractory CLL can further clinically benefit from VenR re-treatment.
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Electroencephalography in the Neonate: Seizure Detection
Continuous Electroencephalography (cEEG) monitoring in neonates provides information on evolving neurological conditions in neonates in the neonatal intensive care unit (NICU). The aim of this study is to clinically validate an automated seizure detection algorithm by comparing EEG interpretations with the gold standard reading by a Paediatric Neurologist. A second aim of the study is to validate the algorithm when housed within a custom built wireless EEG machine and compare that to a commercially available cEEG machine
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FEBCON-ED Study: Does advice to give regular antipyretics for children presenting with a FEBrile CONvulsion to the Emergency Department reduce the rate of seizure reoccurrence within the same febrile illness?
The main purpose of this study is to help determine whether recommending the use of paracetamol or ibuprofen makes any difference to the risk of another febrile convulsion (fit) within the same illness in children aged 6 months- 6 years old who have presented to the ED with a febrile convulsion. The study will also help determine whether paracetamol or ibuprofen given regularly reduces hospital re-attendance with febrile convulsion, health care use and costs. We are also interested in long-term outcomes of children who have had a febrile convulsion. Information will be collected for the study by parent/guardian surveys on days 3,7 and at 12 months, and medical chart review (and optional data linkage) at 12 months post ED attendance. Febrile convulsions are the most common paediatric neurological presentation to the emergency department. Depending on our study findings, we will either confirm current practice, or provide definitive evidence to change practice to update clinical guidelines in AUS & NZ to recommend this simple, low-cost intervention to improve management of febrile convulsions.
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Pilot and feasibility Randomised Controlled Trial (RCT) – Evaluation of Technology-Enhanced, Group-based (TEG) model of care following Carpal Tunnel Release (CTR) surgery.
This research study will evaluate the feasibility and preliminary efficacy of the TEG hand therapy model of care for people post CTR surgery within a public hospital-based (STARS), hand therapy service. It is expected that the outcomes of this study will determine the feasibility and acceptability of the new model of care and determine the feasibility of a future fully powered randomised controlled trial (RCT) that will determine the clinical and cost-effectiveness of the model of care. The TEG model aims to increase efficiency and outcomes, use telehealth delivery to improve patient access and app-based video-guided exercise and monitoring to improve self-management, adherence, and outcomes. Our hypotheses are that the TEG intervention will be acceptable and feasible for patients, and a future, larger randomised trial will be feasible to conduct. We will describe and explore the clinical and cost outcomes from this pilot RCT with due caution to not extrapolate results beyond the feasibility and pilot nature of the study.
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Early communication intervention for infants with or at risk of cerebral palsy
Many people with cerebral palsy (CP) have communication difficulties. Communication is a vital skill for life, with communication difficulties often leading to social, emotional and educational challenges. Research shows that children with CP who are not talking by 2 years of age, are more likely to have permanent communication problems. We know that early targeted training is helpful for infants with CP to learn how to move and walk, but it is less clear when it comes to communication skills. We want to understand if teaching parents communication strategies before their infant is 12 months old leads to better communication skills at 2 years. We will be comparing It Takes Two to Talk® (ITTT) – The Hanen Program® to a usual care group. ITTT teaches parents how to create communication opportunities, to encourage and respond to their infant’s early communication attempts, and to incorporate these strategies into play and their everyday routines. Hanen programs are effective with other groups of young children with disability including Autism Spectrum Disorder, but there is very little high-quality research on any program focusing on early communication in infants with CP. We will be measuring each infant's communication skills, problem-solving, play, social-emotional skills, and parent- infant interactions. We will complete assessments before the intervention begins, and when each infant is 2 years old, to measure if any change has occurred. This study will help us understand the value of early communication intervention for infants with CP and their parents, to provide future guidance regarding effective early communication intervention. We hypothesise that, for infants with or at risk of CP, early parent training with ITTT will be more effective than usual care to improve: Primary Hypothesis [i] Child communication skills on the Communication and Symbolic Behaviour Scales (CSBS), indicated by a difference between groups of 0.5 standard deviations. Secondary Hypotheses [ii] Receptive and expressive communication skills on the Rossetti Infant Toddler Language Scales and/or the Bayley Scales Infant Development (BSID-IV) language scaled scores; [iii] Cognition measured by Bayley Scales Infant Development (BSID-IV) cognitive scaled scores; [iv] Social and emotional development measured by BSID-IV social emotional questionnaire; [v] Parent-infant interactions as measured through detailed video coding and the PaRRis scale at two years of age.
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A telehealth cognitive behavioural therapy program for insomnia in Vietnamese-speaking head and neck cancer survivors
This study aims to evaluate a telehealth cognitive behavioural therapy intervention for insomnia (CBT-I) in Vietnamese-speaking cancer survivors, delivered by a Vietnamese-speaking psychologist. Who is it for? You may be eligible for this study if you are aged 18 years or over and can speak and read Vietnamese, and have completed curative treatment (e.g., surgery, chemotherapy, radiotherapy) for head and neck cancer and are now experiencing clinically significant insomnia symptoms. Study details Participants will undergo a six-session CBT-I intervention delivered weekly over telehealth. Upon completion of the intervention, participants will be asked to complete a few questionnaires regarding acceptability of the treatment and changes in their insomnia. It is hoped that this study will help provide evidence for CBT-I delivered for a Vietnamese population and help address inequalities in accessing evidence-based health care for people from Vietnamese-speaking backgrounds.
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Registry of Stroke Care Quality (RES-Q) Feedback Prompt Intervention Trial
The Registry of Stroke Care Quality (RES-Q) is a global stroke registry used to collect stroke quality of care metrics with benchmarking at both hospital and national levels. RES-Q provides real-time feedback to participating hospitals via reports on demand and dashboards. Providing feedback on the registry data to hospitals and clinicians helps them identify and prioritize areas for stroke care quality improvement. Findings from our recent survey of hospitals participating in RES-Q showed that feedback of RES-Q data to hospital staff and department heads about progress in stroke management was suboptimal. Although there was a high awareness of RES-Q hospital reports and dashboards, staff downloads and views respectively, were low. Current RES-Q feedback mechanisms are passive and rely on the active role of users, which is only partly successful. For RES-Q data to be more effective in driving clinical practice change, evidence-based performance feedback mechanisms are needed. Hence the aim of this study is to evaluate the effectiveness of a feedback prompt intervention involving a ‘push’ email, comprising a message encouraging use of RES-Q data for quality improvement with a link to the RES-Q hospital report and dashboard, sent to the RES-Q hospital coordinators in improving report generating, dashboard viewing and stroke care processes. A randomised controlled trial will be undertaken. Hospitals participating in RES-Q will be randomised to the feedback prompt intervention or a control group. All hospitals registered with RES-Q and entering data to the RES-Q database up to 31st July 2024 will be eligible for inclusion in the study. The study findings have the potential to increase hospitals’ use of RES-Q data to drive practice change within their stroke unit/service.
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Imaging biomarkers of response to immunotherapy in patients with malignant mesothelioma
Immunotherapy targeting immune checkpoint molecules (cell markers) is a new treatment option for patients with mesothelioma. The purpose of this study is to use a novel positron emission tomography (PET) imaging tracer to identify tumour cells that are expressing a specific marker (PD-L1) on mesothelioma tumours using imaging. A new non-invasive method of imaging PD-L1 in people with mesothelioma may allow clinicians to better guide immunotherapy treatment that is personalised for each patient. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with either pleural or peritoneal mesothelioma and you have not yet undergone any immune checkpoint therapy (immunotherapy). Study details This study will enrol participants into one of two stages. Participants enrolled in Stage 1 of this study will be asked to undergo 4 imaging scans in total over a 7 day period. On the first day, participants will undergo two different but similar CT scans. Each scan will involve injection of a specific tracer/dye into a vein 20 minutes prior to the scan being undertaken. Each scan is anticipated to take up to an hour, the total time needed to complete both scans is not anticipated to take more than 3 hours. Participants will then be asked to return 3 days and then between 5-7 days after the first scans to undergo two further scans. These follow-up scans are anticipated to take up to an hour. Participants who choose to enrol in Stage 2 of this study will also be asked to undergo 4 imaging scans in total but this will occur over a longer period of time. Prior to their scheduled anti-cancer systemic therapy, participants will undergo two different but similar CT scans. Each scan will involve injection of a specific tracer/dye into a vein 20 minutes prior to the scan being undertaken. Each scan is anticipated to take up to an hour, the total time needed to complete both scans is not anticipated to take more than 3 hours. Participants will then either receive immunotherapy alone or immunotherapy with chemotherapy. Six weeks after the commencement of systemic therapy, participants will undergo another two scans. A follow-up appointment to discuss any adverse events, the cancer response and a general physical examination of health will be arranged at the next appointment in line with standard of care. It is hoped this research will determine whether this new imaging method is able to accurately identify tumour cells that are expressing PD-L1 and whether this imaging is able to show differences in cell expression over the course of immunotherapy treatment for patients with mesothelioma. Any advance in predicting treatment outcomes would benefit mesothelioma patients by avoiding unnecessary toxicity and better personalising therapy. People in whom the new PET imaging demonstrates a very low chance of immunotherapy response may choose to participate in clinical trials or to be trated with chemotherapy.