ANZCTR search results

To study the effects of Low GI diets in pregnancy. We wish to examine the effect of a low Gi diet on birth weight, development of gestational diabetes and child obesity.

This randomised, placebo-controlled and blinded study aims to quantify the effect of regular oral gabapentin (28 day course) on the incidence and severity of pruritus in children with acute severe burns. Itch will be assessed using standardised age appropriate itch scales. The primary outcome measure will be the proportion of children who are itch free in the final week of a four week study period. Secondary outcomes will include the average severity of itch during the four week study period and the use of conventional rescue anti-pruritic medication. Other secondary outcomes include parental satisfaction and reported pruritus severity at 3months after discharge (obtained through a follow-up phone interview). Although not the primary focus of this study, the effect of gabapentin on pain scores and opioid requirements in these patients will be explored. The is a single-centre, investigator-driven study that will be conducted within the Burns Unit at the Children’s Hospital at Westmead, which is the referral centre for all children with burns in New South Wales. Modest financial support for this study has been obtained from the Society of Paediatric Anaesthetists of New Zealand and Australia.

The aim of this follow-on study is to determine if transcutaneous pulsed radiofrequency treatment (PRFT) can reduce shoulder pain and if multiple treatments are better than one. Shoulder pain is third most common musculoskeletal problem in the general population and accounts for 5% of general practitioner musculoskeletal consults. The incidence of shoulder pain is 6.6 to 25 cases per 1000 patients, with a peak incidence in the fourth through sixth decades. Favourable outcomes have been reported from case series of transcutaneous PRFT described in conference proceedings and the literature. Our earlier double blind “active” versus “sham” study of 2 Hz 20ms 80V transcutaneous PRFT(ACTRN12609000146291) reduced knee pain by 30% at 1 month. Transcutaneous PRFT is a painless, non-invasive, non-destructive, needle-free treatment that applies a pulsing electrical field around the target nerve using surface mounted electrodes to ‘stun’ rather than destroy the nerves, rendering the nerve incapable of transmitting pain signals. It is not known how transcutaneous PRFT works, however, it is thought to induce long lasting biochemical changes in the target spinal nerves without disrupting sensation or motor function. Treatment can be repeated if there is a good response to the first transcutaneous PRFT. 50 patients referred to Frankston Hospital for non-stabilisation surgery for shoulder pain will be invited to participate in a double blind randomised placebo controlled (DBRPC) trial of transcutaneous PRFT. Patients with an unstable shoulder or unable to communicate in English or don’t want to participate will be excluded. The outcome will be determined by comparing pre and post transcutaneous PRFT self-report of pain intensity, global satisfaction, medication use and Oxford Shoulder Score questionnaire.

Evidence suggests that young people with Type 1 diabetes (T1D) are vulnerable to a range of mental health difficulties, including depression and anxiety. Furthermore this vulnerability can be heightened when these young people are isolated from support services, such as is the case for those living in rural areas or experiencing social isolation. The study aims to assist adolescents with T1D and their parents to manage the psychosocial impact of their condition, improve their mental and physical health outcomes, and reduce their risk taking behaviour. The study has two phases. Phase 1 is an interview study of parents (n=10) of adolescents with T1D who are prepared to discuss their experiences of parenting a child with diabetes in relation to their preferences and needs for treatment and internet based interventions. Findings from the parent interviews and an earlier needs analysis study of rural adolescents with T1D and their parents, conducted by the researchers, will be used to revise and supplement the prototype NV-NG adolescent intervention with a parenting intervention. The parent component will be based on an existing parenting program and associated web-resources and will result in an integrated adolescent and parenting program, which will be evaluated in Phase 2 (the Evaluation Phase). The evaluation phase will comprise a randomised control trial (with a wait group control) to evaluate the effectiveness of the NVNG program with a sample of approximately 120 (60 intervention, 60 wait group) adolescents aged 13-18 and one of their parents (n=120, 60 intervention, 60 wait group control). Adolescent/parent dyads will be recruited by a rolling recruitment strategy through The Royal Children’s Hospital Diabetes Outreach Clinics and Monash Medical Centre, in Victoria. Pre-Post intervention/wait measures will be administered via online questionnaires at baseline (t=0), on completion of the program (t=6weeks); and 6 months after completion of intervention/wait. Online questionnaires completed by adolescents and their parents will assess a range of psychosocial factors including: negative emotions (e.g. depression, anxiety), quality of life, diabetes self efficacy, resilience, availability of social support, risk taking behaviours, diabetes self care, and perception of parent/adolescent conflict. Parent questionnaires will assess negative emotions, self efficacy, parent perception of child well being, and family conflict. In addition the adolescents’’ glycylated haemoglobin (HbA1c) results at pre-intervention and follow-up will be used as an objective measure of diabetes control. We aim to establish the extent to which positive outcomes are achieved for both adolescents and their parents.

The study found a significant difference in the median CYP1A2 activity in those of South Asian and European ancestry.

The primary purpose of the study is to assess whether this herbal preparation can manage and improve the symptoms associated with BPH such as increased frequency of urination, difficulties with starting stopping urination and difficulties in postponing urination.

Very preterm infants are particularly susceptible to ventilator induced lung injury and methods of non-invasive respiratory support, the commonest being CPAP are known to reduce the risk of lung injury. However, the optimal pressure levels remain to be determined. Will very preterm infants with respiratory distress syndrome who are being extubated to CPAP initially need higher CPAP pressures than are usually used in order to restore and maintain lung volume? Our hypothesis is that infants extubated to nasal CPAP will initially need higher CPAP pressures than the mean airway pressure delivered by the ventilator prior to extubation in order to restore and maintain lung volume

HIPERSPACE is a trial comparing the use of two types of breathing support for premature infants after they have been extubated (come off a mechanical breathing machine) in the Royal Women’s Hospital (RWH), Adelaide Women's and Children's Hospital (WCH) or Royal Brisbane and Women's Hospital (RBWH) neonatal intensive care units. Premature infants who are born less than 32 weeks of gestation, required support from a mechanical breathing machine, and are planned to be extubated to further breathing support are eligible for inclusion in the trial. The usual way post-extubation breathing support has been provided is by using large prongs in the babies’ nose which transmit a continuous, and regulated, pressure to the baby’s lungs to help them breathe more easily. This support, called nasal CPAP, is quite bulky and requires the infant to wear a tightly-fitted hat, and sometimes causes damage to the infants’ nose. A newer form of support being used around Australian and the world is called high-flow nasal cannulae (HFNC). This method uses smaller prongs in the infant’s nose and blows gas at 2-8 litres per minute into the infant’s airway. It is thought this flow also produces a pressure that helps to keep the lungs open, and has been considered to be more comfortable for the infants. However, despite widespread use, HFNC has not been well studied in premature infants. In the HIPERSPACE trial, premature infants who have been extubated will be randomly assigned to receive either nCPAP or HFNC. The main result we will be interested in from the trial will be which treatment the infants do better on. Infants in the HFNC group who are not coping can be offered nCPAP as ‘rescue’ treatment. Information will be collected about the infants until they are discharged from hospital, including the incidence of lung complications, the amount of different types of breathing support required, rates of complications from using the different types of prongs in the nose, and the comfort of the infant.

Patients with spinal cord injury (SCI) have improved outcomes with a specialized and systematic approach to their care. The management of nontraumatic SCI (NTSCI) is more fragmented compared with traumatic SCI (TSCI). Whereas patients with TSCI are often managed within specialised SCI units Patients with NTSCI can be admitted to a wide range of hospitals, receive care from many different hospital departments, and wait prolonged periods for a rehabilitation bed after they have been accepted as ready for transfer to rehabilitation. There is generally a lack of specialist SCI knowledge and related practical skill among acute hospital staff about the principles of caring for patients with a SCI. This places these patients at higher risk of preventable complications and adverse outcomes. This project is a study of the possible benefits of involving a specialized multidisciplinary consultation team of health care professionals in the management of patients with a recent onset of SCI who are in acute hospitals. The team will function as a mobile unit, assessing and providing therapy recommendations, simple equipment and limited treatment for SCI patients accepted by the Spinal Rehabilitation Unit (SRU) at Caulfield Hospital for admission to the unit and who are waiting for transfer. The median time for transfer is currently over 2 weeks. These patients tend to have a NTSCI. Patients accepted for admission to the SRU at Caulfield Hospital, Alfred Health, will be approached to participate in the study. Those who agree will be randomly allocated to receive either the multidisciplinary consultation team or usual care. It is our hypothesis that the team would significantly improve patient outcomes and prevent SCI complications.

The purpose of the study is to assess the effectiveness of using a manuka honey topical cream in reducing the duration and symptoms of a cold sore outbreak.