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
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
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.Read moreRead less
The Use Of Probiotics To Reduce The Incidence Of Sepsis In Premature Infants.
Funder
National Health and Medical Research Council
Funding Amount
$808,733.00
Summary
Currently, premature infants are born without the normal immune defenses of infants born at the correct time because the protective factors that normally pass from the mother to the baby during the last few months of pregnancy have not had time to do so. In addition the tiny premature infants are at risk because they need the expertise of intensive care and are therefore separated from their parents and their parents' organisms which healthy term infants normally pick up from the birth canal and ....Currently, premature infants are born without the normal immune defenses of infants born at the correct time because the protective factors that normally pass from the mother to the baby during the last few months of pregnancy have not had time to do so. In addition the tiny premature infants are at risk because they need the expertise of intensive care and are therefore separated from their parents and their parents' organisms which healthy term infants normally pick up from the birth canal and their parents skin. The infants commonly develop infections from organisms living on their skin surfaces or inside their lungs, stomach or bowels. The babies are living in a hospital environment which they need to survive, but they may pick up particularly unhealthy organisms (pathogens) that produce toxins, which are difficult to treat even with antibiotics. These infections are so severe that one-fifth of the babies die, even in Australia where facilities for premature infants are excellent. Two recent studies overseas have shown that giving premature babies special preparations of certain probiotic organisms decreases the chance of babie developing infections. Probiotics are organisms that have health benefits. Probiotics tighten the spaces between cells to stop bacteria getting into the body, produce substances that kill other bacteria and promote the production of immunoglobulin A by the baby's own cells. Immunoglobulin A is a substance that lines the bowel wall and protects the baby from invasion by bacteria. This study will offer this probiotic product to very premature babies in a trial to see if it produces additional benefits for our babies in Victoria. Around five hundred babies will be given the product and five hundred will be given the placebo ( a harmless inert product which will look just like the real probiotic). Currently 23% of our babies get the serious infections and this study is powerful enough to see if we can reduce the number by one third.Read moreRead less