The Liggins Institute - media release
A major international study coordinated by researchers at the Universities of Adelaide and Melbourne in Australia and The University of Auckland’s Liggins Institute has confirmed the benefits for premature babies of giving their pregnant mothers repeat doses of corticosteroids if they are at risk of giving birth very prematurely (before 32 weeks or approximately 7 months).
Importantly, the study now demonstrates that at two years of age, the children are showing no adverse effects from the corticosteroids given to their mothers.
The results are published today in the leading international journal, The New England Journal of Medicine.
The study, known as the Australasian Collaborative Trial of Repeat Doses of Steroids, or ACTORDS, is the largest in the world to date, with 982 women and their babies recruited. The study included seven hospitals and 290 women in New Zealand.
The initial results of the trial showed that repeat doses of corticosteroids [to the mothers] reduced breathing and other respiratory problems in the premature babies. However there had been concern that this treatment could inhibit the babies’ later growth and development.
This latest study assessed 96% of the children involved in the trial at two years of age. The children were seen by a paediatrician and a developmental psychologist who assessed vision and hearing, their developmental milestones, body size, blood pressure, behaviour and general health.
"Our new results show that at two years old the children born to mothers who were given repeat corticosteroids were no more likely to have health or development problems than those born to women who weren’t given the repeat doses," says Liggins Institute Deputy Director Professor Jane Harding who coordinated the New Zealand component of the Study. "We saw no differences between the study treatment groups for body size measurements of weight, height and head circumference.
"Our recommendation from these latest results is that, given the clear early health benefits of this treatment, without harm at two years, repeat corticosteroids can be considered beneficial for babies where women are still at risk of very preterm birth a week or more after the first course of corticosteroids."
Comments study leader Professor Caroline Crowther of The University of Adelaide, "Until now there has been a lack of high quality evidence, from well-designed, large randomised clinical trials, assessing the efficacy and safety of repeat doses of [the steroid] betamethasone given to women at ongoing risk of very preterm birth, and no reports on the later health of the children."
Earlier results of the study showed that babies born to women who received repeat corticosteroids were less likely to have respiratory problems after birth and breathing problems were less likely to be severe. These babies were also less likely to have other serious health problems than babies whose mothers did not receive repeat corticosteroids.
Auckland researchers Dr Malcolm Battin, Dr Lindsay Mildenhall, and Professor Jane Harding had also examined the babies who were born in Auckland in greater detail in the first month after birth. They found that babies whose mothers received repeat corticosteroids grew well after birth and did not have increased problems with blood pressure or levels of their natural steroid hormones.
"The next step in the study will be to reassess these children at 6-8 years of age," says Professor Harding.
Some animal experiments have indicated that there might be growth and developmental effects in offspring exposed to repeat doses of antenatal steroids as they grow older.
"We have no cause to be concerned about these children as the study conditions and doses were quite different," adds Prof Harding. "However, it is important that we assess them again during the critical early school years to see if there are any longer term benefits or harms from the treatment."
Funding has been obtained for the New Zealand arm of the school-age follow-up study from the Health Research Council of New Zealand. The study will start next month and is expected to take three years to complete.
Within New Zealand almost 3% of all births or 1,600 women give birth to a baby very pre-term at less than 34 weeks gestation. Babies born early often have respiratory problems and require neonatal intensive care. Not all babies born early survive and those that do are at increased risk of later developmental problems. Researchers at the Liggins Institute are following a number of leads to reduce the incidence of preterm birth and improve the care of babies born preterm.
All women recruited to this study had already been given corticosteroids a week or more before, because they were at risk of preterm birth. A single course of corticosteroids is known to reduce the risk of death, respiratory disease and other problems in preterm babies. This widely accepted treatment was pioneered at National Women’s Hospital in Auckland in the 1970’s by Professor Sir Graham (Mont) Liggins and Professor Ross Howie. Professor Harding’s team have already shown that there are no adverse effects of this treatment up to thirty years later.
Further information: contact Pandora Carlyon, Liggins Institute, p.carlyon@auckland.ac.nz, telephone: 64 9 373 7599, ext 82305 or 021 565 715.
Importantly, the study now demonstrates that at two years of age, the children are showing no adverse effects from the corticosteroids given to their mothers.
The results are published today in the leading international journal, The New England Journal of Medicine.
The study, known as the Australasian Collaborative Trial of Repeat Doses of Steroids, or ACTORDS, is the largest in the world to date, with 982 women and their babies recruited. The study included seven hospitals and 290 women in New Zealand.
The initial results of the trial showed that repeat doses of corticosteroids [to the mothers] reduced breathing and other respiratory problems in the premature babies. However there had been concern that this treatment could inhibit the babies’ later growth and development.
This latest study assessed 96% of the children involved in the trial at two years of age. The children were seen by a paediatrician and a developmental psychologist who assessed vision and hearing, their developmental milestones, body size, blood pressure, behaviour and general health.
"Our new results show that at two years old the children born to mothers who were given repeat corticosteroids were no more likely to have health or development problems than those born to women who weren’t given the repeat doses," says Liggins Institute Deputy Director Professor Jane Harding who coordinated the New Zealand component of the Study. "We saw no differences between the study treatment groups for body size measurements of weight, height and head circumference.
"Our recommendation from these latest results is that, given the clear early health benefits of this treatment, without harm at two years, repeat corticosteroids can be considered beneficial for babies where women are still at risk of very preterm birth a week or more after the first course of corticosteroids."
Comments study leader Professor Caroline Crowther of The University of Adelaide, "Until now there has been a lack of high quality evidence, from well-designed, large randomised clinical trials, assessing the efficacy and safety of repeat doses of [the steroid] betamethasone given to women at ongoing risk of very preterm birth, and no reports on the later health of the children."
Earlier results of the study showed that babies born to women who received repeat corticosteroids were less likely to have respiratory problems after birth and breathing problems were less likely to be severe. These babies were also less likely to have other serious health problems than babies whose mothers did not receive repeat corticosteroids.
Auckland researchers Dr Malcolm Battin, Dr Lindsay Mildenhall, and Professor Jane Harding had also examined the babies who were born in Auckland in greater detail in the first month after birth. They found that babies whose mothers received repeat corticosteroids grew well after birth and did not have increased problems with blood pressure or levels of their natural steroid hormones.
"The next step in the study will be to reassess these children at 6-8 years of age," says Professor Harding.
Some animal experiments have indicated that there might be growth and developmental effects in offspring exposed to repeat doses of antenatal steroids as they grow older.
"We have no cause to be concerned about these children as the study conditions and doses were quite different," adds Prof Harding. "However, it is important that we assess them again during the critical early school years to see if there are any longer term benefits or harms from the treatment."
Funding has been obtained for the New Zealand arm of the school-age follow-up study from the Health Research Council of New Zealand. The study will start next month and is expected to take three years to complete.
Within New Zealand almost 3% of all births or 1,600 women give birth to a baby very pre-term at less than 34 weeks gestation. Babies born early often have respiratory problems and require neonatal intensive care. Not all babies born early survive and those that do are at increased risk of later developmental problems. Researchers at the Liggins Institute are following a number of leads to reduce the incidence of preterm birth and improve the care of babies born preterm.
All women recruited to this study had already been given corticosteroids a week or more before, because they were at risk of preterm birth. A single course of corticosteroids is known to reduce the risk of death, respiratory disease and other problems in preterm babies. This widely accepted treatment was pioneered at National Women’s Hospital in Auckland in the 1970’s by Professor Sir Graham (Mont) Liggins and Professor Ross Howie. Professor Harding’s team have already shown that there are no adverse effects of this treatment up to thirty years later.
Further information: contact Pandora Carlyon, Liggins Institute, p.carlyon@auckland.ac.nz, telephone: 64 9 373 7599, ext 82305 or 021 565 715.
