School-Age Outcomes Of Very Preterm Infants And Antenatal Magnesium Sulphate Therapy - A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$675,050.00
Summary
Despite recent major advances in care around the time of birth that have led to large increases in the survival rates for very preterm babies, the rate of adverse long-term health problems has not diminished in survivors, and remains too high compared with children not born very preterm. In particular they have higher rates of substantial problems with the way their brain works, particularly affecting their movement, vision, hearing, thinking and talking. We have just concluded a large clinical ....Despite recent major advances in care around the time of birth that have led to large increases in the survival rates for very preterm babies, the rate of adverse long-term health problems has not diminished in survivors, and remains too high compared with children not born very preterm. In particular they have higher rates of substantial problems with the way their brain works, particularly affecting their movement, vision, hearing, thinking and talking. We have just concluded a large clinical trial in Australia and New Zealand of magnesium sulphate which was given to mothers who were likely to deliver their baby too early (before 30 weeks of pregnancy). We have been able to show, for the first time, that magnesium sulphate was able to halve the rate of substantial problems with movement in 2 year old survivors, from 6% to 3%. 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. We plan to assess the 1061 survivors from our earlier clinical trial of magnesium sulphate therapy at ages from 7-8 years, when they are at school. We will assess their movement and other important areas of their brain function, as well as their school progress and general health and growth. If we find important improvements in health at school-age of these children caused by magnesium sulphate therapy, without any substantial counterbalancing side-effects, magnesium sulphate will probably become standard therapy in mothers who are likely to deliver their baby very early. This will lead to a reduction in the burden of illness in the community caused by being born too early.Read moreRead less
Neuroprotective Role Of Sulphate Among Preterm Babies (SuPreme Study)
Funder
National Health and Medical Research Council
Funding Amount
$749,338.00
Summary
Magnesium sulphate administered to mothers shortly before preterm birth, reduces the risk of cerebral palsy. The mechanism of its neuroprotective effect is unknown, and our studies suggest sulphate is the protective element. Preterm babies rapidly become sulphate deficient, and magnesium sulphate mitigates this deficiency in most infants. In this study we will investigate whether low blood sulphate levels at 1 week of age correlate with cerebral palsy.
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
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.
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