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
SCHOOL-AGE OUTCOME FOR VERY TINY/PRETERM CHILDREN BORN IN VICTORIA IN 1991-92
Funder
National Health and Medical Research Council
Funding Amount
$252,956.00
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. Several new treatments have helped to improve their survival rate, but some have the potential to cause long-term harm to the developing baby's brain or lung, and may cause lifelong problems with thinking, walking, talking, seeing, hearing, growth or breathing. Babies who are very tiny (born weighing less than 1000 g), or born very early (bo ....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. Several new treatments have helped to improve their survival rate, but some have the potential to cause long-term harm to the developing baby's brain or lung, and may cause lifelong problems with thinking, walking, talking, seeing, hearing, growth or breathing. 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 assessed long term (to 8-9 years of age), as broadly as possible, and in comparison with normal birthweight (NBW, birthweight >2499 g) children. Outcomes will encompass academic progress and behaviour, brain function, general health, growth, and respiratory health. We will compare the outcomes for very tiny-preterm children who were treated with several of these new therapies with those who were not so treated. We will assess whether alternative measures of long term outcome that assess the quality of life are applicable to very tiny-preterm children. If so, these measures could be used much more widely, since they are cheaper and less time-consuming.Read moreRead less
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
Early School-Age Outcomes After Exposure To Repeat Prenatal Corticosteroids - A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$1,083,964.00
Summary
AIMS OF THE RESEARCH We have recently concluded a large clinical trial in Australia and New Zealand of repeat dose of antenatal corticosteroids given to women who were likely to deliver their baby too early (before 34 weeks of pregnancy). We have been able to show that repeat doses of corticosteroids before birth significantly reduces the risk of the baby developing respiratory difficulties after birth from 41.4% to 32.8%. However, we are not sure if this potentially important improvement will t ....AIMS OF THE RESEARCH We have recently concluded a large clinical trial in Australia and New Zealand of repeat dose of antenatal corticosteroids given to women who were likely to deliver their baby too early (before 34 weeks of pregnancy). We have been able to show that repeat doses of corticosteroids before birth significantly reduces the risk of the baby developing respiratory difficulties after birth from 41.4% to 32.8%. However, we are not sure if this potentially important improvement will translate into better outcomes for the children as they grow older and reach school-age. As there are many examples of treatments given around the time of birth that have been shown to have some short-term benefits, but substantial long-term harms, we must be as certain as we can be that any advance in one small area of health is not counterbalanced by disadvantages in other health areas. This is particularly important to find out for repeat antenatal corticosteroids given the earlier conflicting reports from non-randomised studies. We plan to assess the 1085 survivors from our earlier clinical trial of repeat dose of prenatal corticosteroids when they are of early school age. We will assess their movement and other important areas of their brain function, as well as their school progress, blood pressure, lung function and general health and growth. EXPECTED OUTCOMES OF THE RESEARCH If we find important improvements in health outcomes at school-age in children exposed to repeat corticosteroids, without any substantial couterbalancing adverse effects, repeat steroids will be recommended standard therapy in women who are likely to give birth to their baby very early. This will lead to a reduction in the burden of ill health.Read moreRead less