A Randomised Controlled Trial Of A Fluid Containing 140mmol/L Of Sodium Compared To A Fluid Containing 77mmol/L Of Sodium For Maintenance Intravenous Fluid Therapy In Hospitalised Children.
Funder
National Health and Medical Research Council
Funding Amount
$183,959.00
Summary
Intravenous fluid therapy is one of the most common and important treatments for children in hospital. In spite of this we know very little about what fluid should be used and there is now good evidence that children are experiencing adverse outcomes because of fluid treatment. The aim of this trial is to determine which intravenous fluid is best in children. It will be the largest and most relevant intravenous fluid trial performed in children. The results will have an immediate impact on treat ....Intravenous fluid therapy is one of the most common and important treatments for children in hospital. In spite of this we know very little about what fluid should be used and there is now good evidence that children are experiencing adverse outcomes because of fluid treatment. The aim of this trial is to determine which intravenous fluid is best in children. It will be the largest and most relevant intravenous fluid trial performed in children. The results will have an immediate impact on treating children worldwide.Read moreRead less
Repeated Prenatal Corticosteroids: Effects On Childhood Development, Behaviour, Growth And Health
Funder
National Health and Medical Research Council
Funding Amount
$265,900.00
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 preterm birth, 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.Read moreRead less
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.Read moreRead less
A Prospective Randomised Trial Comparing Nasogastric With Intravenous Hydration In Children With Bronchiolitis
Funder
National Health and Medical Research Council
Funding Amount
$886,817.00
Summary
This project aims to compare the two methods currently being used of providing fluid to young children who have a viral infection of the lungs called bronchiolitis. The methods of giving fluids are through a tube placed though the nose, down the food pipe, into the stomach (nasogastric tube), or through a drip in the child's vein (intravenous). We hope to show that one of these methods is better than the other and allows children to be sent home from hospital earlier, and cost less.
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.
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.
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.Read moreRead less
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.Read moreRead less
Efficacy And Safety Of Methylxanthines In Very Low Birth Weight Infants
Funder
National Health and Medical Research Council
Funding Amount
$221,136.00
Summary
With improving technologies and medications the numbers of very premature babies surviving to leave hospital has increased over the last two decades. However these babies are at increased risk of having brain damage in the form of mental retardation and cerebral palsy. These problems impose a major burden on the individuals, their families and society at large. This study attempts to identify whether or not a commonly used drug is safe in these babies or whether it contributes to brain damage in ....With improving technologies and medications the numbers of very premature babies surviving to leave hospital has increased over the last two decades. However these babies are at increased risk of having brain damage in the form of mental retardation and cerebral palsy. These problems impose a major burden on the individuals, their families and society at large. This study attempts to identify whether or not a commonly used drug is safe in these babies or whether it contributes to brain damage in some cases. Many premature babies have difficulty breathing by themselves because their brain does not send regular messages to their lungs telling them to expand. A class of drugs which includes caffeine has been shown to stimulate breathing in babies and has been thought to reduce the amount of support these babies require from a ventilator in the first weeks of life. The safety of these drugs has not been adequately demonstrated in premature babies and there is some evidence from animal studies that they may disrupt the developing brain. Results in human babies are inconclusive and concerns remain regarding the long term effects of caffeine. The question of whether caffeine usage increases the risk of mental retardation or cerebral palsy is a very important one given the almost universal usage of this or similar drugs in premature babies. We will find out whether babies given caffeine as newborns perform as well at 18 months of age as babies not given the drug.Read moreRead less
Which Oxygen Saturation Level Should We Use For Very Premature Infants? A Randomised Controlled Trial.
Funder
National Health and Medical Research Council
Funding Amount
$2,215,600.00
Summary
Retinopathy of prematurity (ROP) is a serious complication of premature birth, and is a major cause of preventable blindness. Babies who are born before 28 weeks gestation are at greatest risk for developing severe ROP. Oxygen is one of the most common therapies used daily to care for premature babies, but high oxygen levels are one of multiple factors that can disrupt normal eye development and contribute to ROP. The current dilemma is that doctors and nurses do not know what level of oxygenati ....Retinopathy of prematurity (ROP) is a serious complication of premature birth, and is a major cause of preventable blindness. Babies who are born before 28 weeks gestation are at greatest risk for developing severe ROP. Oxygen is one of the most common therapies used daily to care for premature babies, but high oxygen levels are one of multiple factors that can disrupt normal eye development and contribute to ROP. The current dilemma is that doctors and nurses do not know what level of oxygenation is both safe and most effective for these babies. Whilst higher oxygen levels may increase ROP and other respiratory problems, it is possible that lower oxygen levels may affect other long-term outcomes. Because there is no definitive evidence regarding appropriate oxygenation, a wide spectrum of opinion and practice currently exist. Australia is conducting The Benefits of Oxygen Saturation Targeting Trial (BOOST II), a research study to solve this dilemma. BOOST II is a randomised, double blind, clinical trial, which will study the effects of using two ranges of oxygen saturation, 85-89% versus a higher range 91-95% for infants born before 28 weeks gestation. Both of these oxygen level ranges are currently used in normal practice. Patient safety will be monitored closely, and each infant will have their development, vision and health assessed by specialists at 18-24 months of age (plus the number of weeks premature), to see whether there is difference in survival free of major disability between the two groups. 1200 Australian infants will participate. This study will answer important questions about the benefits and risks of higher versus lower oxygen levels, and will improve the care of thousands of Australian children and millions more worldwide.Read moreRead less