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Field of Research : Paediatrics
Research Topic : RANDOMISED CLINICAL
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  • Funded Activity

    Postnatal Dexamethasone In Tiny Babies: Does It Do More Good Than Harm?

    Funder
    National Health and Medical Research Council
    Funding Amount
    $394,688.00
    Summary
    The survival rate for tiny or very premature babies has improved dramatically in recent times, from below 10% in the 1960s to greater than 70% in the 1990s. However, some of these babies require prolonged periods of help with breathing and oxygen treatment to survive, and many develop a form of chronic lung disease in the newborn period. A powerful group of drugs, known as corticosteroids, have been used to treat or prevent this chronic lung disease in newborn babies, with some success in shorte .... The survival rate for tiny or very premature babies has improved dramatically in recent times, from below 10% in the 1960s to greater than 70% in the 1990s. However, some of these babies require prolonged periods of help with breathing and oxygen treatment to survive, and many develop a form of chronic lung disease in the newborn period. A powerful group of drugs, known as corticosteroids, have been used to treat or prevent this chronic lung disease in newborn babies, with some success in shortening the time that the babies need help with breathing. However, corticosteroids have the potential to cause long-term harm to the developing baby's brain, and may cause lifelong problems with thinking, walking, talking, seeing or hearing. We want to test in a clinical trial if corticosteroids, specifically dexamethasone, can reduce the need for help with breathing and the rate of chronic lung disease without causing long-term problems to the developing baby's brain. Babies who are very tiny (born weighing less than 1000 g), or born very early (born before 28 weeks of pregnancy, or more than 12 weeks premature) will be eligible for this study if they still need help with their breathing after one week of age from a machine called a respirator, and their doctor considers that corticosteroids might be helpful to the baby's breathing. Some babies will receive dexamethasone and other babies will be treated with a harmless placebo - chance will decide which treatment the baby receives. All other aspects of the babies' care will continue as normally. Children who survive to 2 years of age will be assessed fully to determine if they have any problems with their health, including problems with their thinking, walking, talking, seeing or hearing. We will determine if dexamethasone is helpful or not for very tiny or very premature babies who have breathing problems after the first week of life. We will also measure the economic impact of dexamethasone treatment in these babies.
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    Rapid Ferric Carboxymaltose Infusion (Ferinject) For Iron Deficiency Anaemia In Aboriginal Children: A Randomised Controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,236,421.00
    Summary
    The “Rapid Iron Infusion Project” will assess whether an intravenous infusion of ferric carboxymaltose (Ferinject) given over 15 minutes in children prior to their discharge from hospital will reduce the risk of ongoing anaemia. The potential benefits of iron infusion include higher haemoglobin levels, fewer painful iron injections over the next 6-9 months, better adherence to recommended treatment, and less use of primary health care resources.
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    Child Health At Two Years Corrected Age After Antenatal Exposure To Dexamethasone Or Betamethasone; A Randomised Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,777,593.00
    Summary
    Both dexamethasone or betamethasone, given to women at risk of preterm birth substantially improve neonatal and child health. There are conflicting reports as to whether dexamethasone is better than betamethasone? This randomised trial will assess this. If dexamethasone is more beneficial, there will be fewer deaths and fewer disabled children. This will be of great importance for the care of women at risk of preterm birth, their children and health services in Australia and internationally.
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    Does Antenatal Magnesium Sulphate Given To Women At Risk Of Preterm Birth Between 30 And 34 Weeks' Gestation Reduce The Risk Of Death Or Cerebral Palsy In Their Children? - A Randomised Controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,978,760.00
    Summary
    Antenatal magnesium sulphate is recommended prior to preterm birth at less than 30 weeks’ gestation. Whether there are benefits at later gestations is uncertain. This study is assessing whether magnesium sulphate given to women at risk of very preterm birth between 30 to 34 weeks’ gestation increases the chance of their baby surviving without cerebral palsy.
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    Vaginal Progesterone For The Prevention Of Neonatal Respiratory Distress Syndrome - A Randomised Controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $935,107.00
    Summary
    Respiratory distress syndrome is a significant problem for babies born preterm. For these babies, a significant number will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks.
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    Repeated Prenatal Corticosteroids: Effects On Childhood Development, Behaviour, Growth And Health

    Funder
    National Health and Medical Research Council
    Funding Amount
    $718,055.00
    Summary
    Infants born preterm are at high risk of needing help with their breathing to survive. Corticosteroids given to the mother prior to preterm birth can substantially reduce these risks, although the beneficial effects of these drugs only seem to last seven days. Because of this there has been a tendancy to repeat the dose of prenatal steroids after seven days in women who remain at continued risk of very preterm birth. There has been no formal assessment of whether or not repeating the dose of pre .... Infants born preterm are at high risk of needing help with their breathing to survive. Corticosteroids given to the mother prior to preterm birth can substantially reduce these risks, although the beneficial effects of these drugs only seem to last seven days. Because of this there has been a tendancy to repeat the dose of prenatal steroids after seven days in women who remain at continued risk of very preterm birth. There has been no formal assessment of whether or not repeating the dose of prenatal corticosteroids is beneficial or harmful. In this clinical trial we will test what effect, if any, repeat doses of corticosteroids given to women who remain at risk of pretermbirth, have on children at the age of two years Women are eligible for the trial if at of less than 32 weeks of pregnancy, they have received corticosteroids seven or more days ago, and they are considered to be at continued risk of preterm birth. Women are randomised to one of the two treatment groups. Half the women will receive a weekly intramuscular injection of corticosteroids up to the time of birth or 32 weeks gestation, whichever is earlier, whilst the risk of very preterm birth remains. The other half of the women will receive a saline placebo injection. Chance will decide which treatment the women receives. In this study all children who survive to 2 years corrected age will be assessed to see if they have any problems with their health, growth and development. In particular we will assess how well they can walk, talk, understand, see and hear. The trial will be able to assess whether repeat doses of prenatal corticosteroids are helpful or not for infants at risk of being born very preterm by comparing the short term effects on infant health after birth and whilst in hospital with the effects on the child's later health, growth and development. An economic assessment of repeat doses of prenatal corticosteroids will be made in these children.
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    Funded Activity

    Vaginal Progesterone For The Prevention Of Neonatal Respiratory Distress Syndrome - A Randomised Controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,243,111.00
    Summary
    Respiratory Distress Syndrome is a significant problem for babies born very preterm (at less than 34 weeks of pregnancy). For these babies, over 90% will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks. This randomised controlled trial will assess the use of v .... Respiratory Distress Syndrome is a significant problem for babies born very preterm (at less than 34 weeks of pregnancy). For these babies, over 90% will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks. This randomised controlled trial will assess the use of vaginal progesterone therapy for women at risk of preterm birth as a means of reducing the risk of neonatal Respiratory Distress Syndrome and improving the outcomes of their babies.
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    A COMMUNITY BASED STRENGTH TRAINING PROGRAM TO IMPROVE WORK TASK PERFORMANCE IN YOUNG ADULTS WITH DOWN SYNDROME

    Funder
    National Health and Medical Research Council
    Funding Amount
    $180,649.00
    Summary
    This study will compare the outcomes of a 10 week twice a week community-based weight training program for young adults with Down syndrome with an art program. It will establish if a student-led exercise program can improve their performance of work tasks and their activity levels. Should the program prove beneficial, we aim to achieve the long-term outcome of exercise being implemented as a sustainable, inclusive recreation option for this group.
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    RCT Of Headbox Oxygen Vs CPAP For Neonatal Respiratory Distress In Non-tertiary Hospitals

    Funder
    National Health and Medical Research Council
    Funding Amount
    $225,500.00
    Summary
    Each year in NSW hundreds of babies are transferred from local general hospital nurseries to a hospital with Neonatal Intensive Care Unit (NICU) because of breathing difficulties. Frequently, mothers are unable to accompany their babies at the time of transfer, leading to stress. When a mother is eventually transferred she is often separated from her partner and local supports causing further anxiety. In addition, if a baby has to be transferred, invasive procedures may be needed to ensure safet .... Each year in NSW hundreds of babies are transferred from local general hospital nurseries to a hospital with Neonatal Intensive Care Unit (NICU) because of breathing difficulties. Frequently, mothers are unable to accompany their babies at the time of transfer, leading to stress. When a mother is eventually transferred she is often separated from her partner and local supports causing further anxiety. In addition, if a baby has to be transferred, invasive procedures may be needed to ensure safety. Currently, babies who need oxygen in a local hospital are placed in a crib with a clear plastic box around their head and oxygen is run into the box (headbox oxygen). There is an alternative method of providing oxygen called CPAP (Continuous Positive Airway Pressure). This involves giving the oxygen directly into the baby's nose via soft rubber prongs. CPAP has been used since the 1970's. It is the main form of respiratory support for infants in many NICUs in Australia and the world. There is some evidence that death and lung disease may be reduced. However, the babies in these studies are sicker and smaller than babies in local hospital nurseries. CPAP is used in some local nurseries in New Zealand, however no studies have been done to see if CPAP reduces the need for inter-hospital transfer. The study will involve hospitals that have been selected because of their level of on site medical and nursing staff. These hospitals will have support and advice from two NICUs that use CPAP as their main form of respiratory support. Babies who need oxygen will be randomly allocated to either have headbox oxygen or CPAP. If the baby becomes so unwell such that certain preset criteria are met, the baby will be transferred to a NICU in the usual way. If CPAP safely reduces the need for inter-hospital transfer, many parents will be saved the anxiety associated with transfer, and the separation it often causes.
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    A Randomised Controlled Trial Of A Community-based Weight Management Intervention In Obese Adolescents

    Funder
    National Health and Medical Research Council
    Funding Amount
    $79,534.00
    Summary
    This research will explore various aspects of managing overweight and obesity in adolescence, including a review of previous studies. The central focus will be participants' weight, health and behavioral outcomes in a randomised controlled trial of a community-based weight management program for 13-16 year olds. A focus group study will be conducted to increase understanding of parent-adolescent communication regarding overweight and the decision to seek treatment.
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