ANZCTR search results

To look at the response of the heart and lungs to a procedure where the pressure delivered by a mechanical ventilator is increased to increase the level of oxygen delivered to a patient. Subjects are blinded.

Many babies are born with respiratory distress and require care in a Special Care Nursery (SCN). Whilts most of these babies get better with oxygen and other routine supports a number have to be transferred to a Neonatal Intensive Care Unit (NICU). Such a transfer has a major impact on the health of the baby and on the family unit and incurs a significant cost. Continuous Positive Airways Pressure (CPAP) is used to treat infants with respiratory distress in Australian NICUs. This proposal seeks to compare, by randomised trial, nasal CPAP to head box oxygen in SCN, as means of early treatment of respiratory distress. The study is designed to be able to detect a 50% reduction in the number of babies meeting criteria that would ordinarily result in transfer to NICUs.

Antenatal depression, anxiety and the difficulties associated with adjusting to parenthood can have long-term negative effects on parents and their children. This study will test whether an 8-week self-help antenatal intervention with telephone support will reduce postnatal negative mood and parenting stress, increase health service uptake, as well as facilitate adjustment to parenthood in couples receiving the program compared to couples not receiving the program. 100 women with elevated scores (>12) on the Edinburgh Postnatal Depression Scale (EPDS) and/or the Risk Assessment Checklist (RAC) and their partners, and 100 women with scores below the threshold (<13) on the EPDS and the RAC and their partners will be randomised to either intervention or control groups. Participants will be assessed by self-administered questionnaires at 20-32 weeks of pregnancy and 12 weeks postpartum.

Phase 3 This study compares standard abdominal surgery with laparoscopic (keyhole) surgery for women with early stage cancer of the endometrium (lining of the womb). Who is it for? You can join this study if you have early stage cancer of the endometrium (lining of the womb) that has not spread beyond the wall of the womb. This is determined by scans before the operation. Trial details Participants will be randomly divided into two groups. One group receives standard abdominal surgery and the other receives laparoscopic (keyhole) surgery for removing the uterus (womb). Women will have an equal chance of being offered one or other surgical approaches and will be followed for up to 4 ½ years to trace any women whose cancers return. Normally, surgery is carried out through a cut just above the pelvic bone, and the womb is removed together with ovaries and fallopian tubes. Lymph nodes may also have to be removed. For almost all women, this is curative surgery. This new technique may reduce some of the problems that people may experience immediately after surgery and in the longer term. The study is seeking to understand whether the same excellent outcomes can be achieved with surgery that is usually better tolerated.

The screening program with flexible sigmoidoscopy has been operating for 10 years. Up to 40% of participants do not reattend, largely due to concerns over pain and discomfort and our data indicates that high pain scores and poor bowel cleansing are associated with reduced detection of colonic adenomas. We aim to assess the efficacy of peppermint oil in improving adenoma detection by reducing pain. Additionally, the efficacy of two enemas rather than the standard one enema in improving bowel cleansing and adenoma detectionwill be assessed. Participants, the procedualist, staff interviewing subjects after sigmoidoscopy and the data analyst are blinded to the nature of the interventions. Study will be unblinded following adequate recruitment

This study was originally planned to enroll 600 patients in a proscpective evaluation of a new stent developed for use in a special class of coronary artery blockages located at bifurcations. Bifurcations are lesions that occur just at the point where 1 vessel splits into two. Bifurcation lesions have been shown in the past to be difficult to treat with conventional stents and techniques. The study device is desigined specifically for these types of lesions. The study is designed to show that use of the new stent results in lower clinical event rates compared to a historical control group. Follow up will occur frequently in the first year (1, 6, 9 and 12 months), then annually for 5 years. The study was modified to only include enrollment for the 300 subjects planned in Europe, Australia, and New Zealand. The 300 subjects that were planned for enrollment in the United States will instead be enrolled under a randomized trial as (newly) required by the US FDA.

The standard treatment of very premature babies has been intubation and ventilation at birth. Recent non-randomised studies have shown that some of these babies can be managed with oxygen provided under a low continuous positive pressure into the nose and that this may improve some of their outcomes. This trial will be the first randomised trial to compare these two treatments and determine which has the optimal outcome for the baby.

HYPOTHESIS: Pentoxifylline may be beneficial as a specific secondary prophylaxis for necrotising enterocolitis (NEC) in preterm neonates. AIM: To evaluate the safety and efficacy of pentoxifylline as a secondary prophylaxis for preventing progression of NEC in preterm neonates in a randomised, placebo-controlled pilot trial. BACKGROUND: NEC is the most common neonatal gastrointestinal emergency. NEC related mortality (20-40%) and morbidity including long-term neurodevelopmental impairment and the socioeconomic burden continue to be high. Despite extensive research the pathogenesis of NEC remains poorly understood. No single specific strategy exists for either prevention or treatment of NEC. Pentoxifylline is a non-steroidal anti-inflammatory agent with diverse immunomodulatory properties including inhibition of TNF alpha- an important pro-inflammatory cytokine implicated in the pathogenesis of NEC. It has been shown to significantly reduce the incidence and severity of NEC in an experimental trial. PATIENTS AND METHODS: Eligibility criteria: Preterm neonates (gestation: <32 weeks) with definite (equal to or greater than Stage II) NEC will be eligible for enrolment after the diagnosis of the illness is made and informed parental consent is obtained. Exclusion criteria: (1) Failure to obtain informed parental consent (2) Presence of congenital malformation/s (3) Presence of chromosomal aberrations (4) Presence of hepatic or renal impairment (5) Exposure to pentoxifylline within 1 week prior to enrolment. Randomisation, allocation, blinding: The Coordinating Pharmacist (CP) will supply the medication packs containing either the placebo or pentoxifylline, identified only by a number designating the allocation. Only the supplier and the CP will be aware of the allocation. A software program written for the trial will perform randomisation. The electronic online randomisation will be stratified by neonatal gestational age (up to 27 weeks and at /above 28 weeks) within each participating center to ensure that the smallest and sickest neonates would be equally distributed between pentoxifylline and placebo groups. Pentoxifylline and placebo (normal saline) solutions have identical appearance and will be supplied in identical looking ampoules. The parents and all study personnel including the statisticians will be masked to the allocation status. Drug protocol: Enrolled neonates will be allocated to an IV infusion of either pentoxifylline or an equal volume of placebo at 5mg/kg/hour for 12 hours a day (60mg/kg/day) for 2 consecutive days, followed by infusion for 6 hours a day (30mg/kg/day) for the next 4 consecutive days. Statistical considerations: The estimated sample size for the pilot trial is 80 (Pentoxifylline: 40, Placebo: 40). Pentoxifylline safety will be assessed by analysing the adverse events in the first 30 neonates allocated to the drug. Guidelines for monitoring and analysing adverse events are provided. The results will help in determining the feasibility and sample size of a large definitive trial. Subgroup: A subgroup analyses is planned for neonates with gestational age up to 27 weeks given that the mortality and morbidity including long term neurodevelopmental impairment related to NEC is significantly higher in them. Primary and secondary outcomes: The primary outcome would be the safety and efficacy of pentoxifylline in reducing the progression of NEC from at or greater than Stage II to Stage III and/or death. Adverse events of interest will include systemic hypotension and intraventricular hemorrhage. The secondary outcomes will include the duration of hospital stay and TPN support, and the time to full enteral feeds (150 ml/kg/day) after NEC. OUTCOMES AND SIGNIFICANCE: Our research has the potential for providing a simple strategy for preventing progression of NEC in preterm neonates that is associated with significant mortality and morbidity including long-term neurodevelopmental impairment.

The study is designed to look at the effect of supplementation with low dose mixed vitamin E and sesame, either alone on in combination on blood pressure in people who already have elevated blood pressure. The study will be double-blinded with both the study co-ordinator and participants blinded to the tocopherol treatment. However, because of a noticeable taste difference between the placebo spread and the sesame spread, this will not be able to be blinded

A crossover trial of mifepristone for the treatment of depression in Parkinson's disease. Participants will be randomly assigned to either mifepristone or placebo during the first part of the study and then assigned to the other during the second part of the study. The trial will be double blinded - the placebo and mifepristone are to be dispensed by a hospital pharmacy according to a code generated by a statistician. Participants and investigators will not know which has been dispensed until the completion of the trial.