Randomised Controlled Trial Of Therapeutic Pulmonary Lavage In Meconium Aspiration Syndrome
Funder
National Health and Medical Research Council
Funding Amount
$182,550.00
Summary
Meconium aspiration syndrome (MAS) is a serious respiratory disease of full term infants, which can lead to very severe respiratory failure. It is caused by the inhalation of meconium, the secretion of the fetal intestine, into the lung at or prior to delivery. As a result, the airways and air sacs within the lung are damaged, leading to difficulty with breathing and poor oxygen levels. About one-third of all infants with MAS require mechanical ventilation in the first days of life, and are ofte ....Meconium aspiration syndrome (MAS) is a serious respiratory disease of full term infants, which can lead to very severe respiratory failure. It is caused by the inhalation of meconium, the secretion of the fetal intestine, into the lung at or prior to delivery. As a result, the airways and air sacs within the lung are damaged, leading to difficulty with breathing and poor oxygen levels. About one-third of all infants with MAS require mechanical ventilation in the first days of life, and are often extremely difficult to manage. At present, the main treatments given to a ventilated infant with severe MAS are supportive, rather than curative. Lung cleansing procedures are not part of routine care in this condition, even though removal of meconium from the lung may reduce the amount of damage that occurs. This project is a randomised controlled trial of a lung cleansing procedure called lung lavage in ventilated infants with severe MAS. During the lung lavage, a quantity of cleansing fluid containing a natural substance called surfactant is introduced into the lung, and then removed by suctioning. This procedure cleanses the lung of some of the meconium, and in preliminary testing, appears to be safe and well-tolerated even in the sickest infants. In the proposed trial, we will randomly allocate ventilated infants with severe MAS to receive either a lung lavage procedure, or routine care. This will take place within 24 hours of birth. We are looking to see whether the lavage procedure shortens the duration of ventilation, oxygen therapy or hospitalisation. Because there are only a small number of ventilated infants with MAS at any one centre per year, we will involve as many Australian neonatal intensive care units as we can in the study. We aim to enrol 66 infants in the trial, of whom half will receive lavage therapy.Read moreRead less
We are an international team committed to clinical trials to improve survival without disability in newborn babies. We plan a randomised trial to confirm if bovine lactoferrin, an inexpensive dairy protein, reduces death or major morbidity and increases total breast milk intake in 1,500 very low birthweight babies in neonatal intensive care units
Characterization Of Sex-Specific Differences In Cardiovascular Adaptation In The First Three Years Of Life
Funder
National Health and Medical Research Council
Funding Amount
$567,725.00
Summary
Male babies born significantly premature are up to twice likely to die than females. The reasons for this are unknown. This study will determine the cardiovascular differences in male and female babies born preterm and will examine how they adapt over the first 5 days. Defining the mechanisms that contribute to the difference in mortality between the sexes will also show how changes starting around birth affect the way the blood pressure system functions for life, a major lifetime stroke risk.
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
International Neonatal Immunotherapy Study (INIS): A Randomised Trial Of Intravenous Immunoglobulin For Neonatal Sepsis
Funder
National Health and Medical Research Council
Funding Amount
$1,151,250.00
Summary
There is promising evidence that treatment of serious infection in babies with a product naturally occuring in blood, intravenous immunoglobulin (IVIG), may reduce deaths by 40% and reduce brain damage in survivors. This would reduce the social, emotional and financial burden of disability on families, health services and society. In financial terms alone, caring for a severely disabled child costs an extra $50,000 per year. However, more evidence is needed before IVIG can be introduced as routi ....There is promising evidence that treatment of serious infection in babies with a product naturally occuring in blood, intravenous immunoglobulin (IVIG), may reduce deaths by 40% and reduce brain damage in survivors. This would reduce the social, emotional and financial burden of disability on families, health services and society. In financial terms alone, caring for a severely disabled child costs an extra $50,000 per year. However, more evidence is needed before IVIG can be introduced as routine treatment for serious infection in the newborn. The International Neonatal Immunotherapy Study (INIS) is a randomised trial to study the potential benefits of IVIG in 5,000 newborn babies in 150 centres world wide. 26 centres are in Australia and New Zealand, whose expected contribution of 1,500 babies will be vital to the success of the study. INIS is supported by the Commonwealth Government and Australian Red Cross Blood Service, who will oversee the supply and distribution of IVIG, and the NHMRC Clinical Trials Centre, who will coordinate the study. Infants will have a detailed specialist assessment at 2 years of age and a parent questionnaire will be completed, to assess their development. An economic evaluation will be performed to estimate the long-term savings to Australian Health Services and families associated with the IVIG therapy. The IVIG product to be used in Australia is Intragam P, manufactured by CSL, who have an unrivalled safety record. CSL has been making IVIG since 1989 and no transmission of HIV or hepatitis viruses has ever been reported. CSL estimate the risk of transmission of these viruses by IVIG is under 1 in 10 million treatments. INIS will provide reliable evidence about IVIG, a treatment with minimum known risk that may benefit thousands of Australian children and millions more worldwide.Read moreRead less
Should Very Premature Babies Receive A Placental Transfusion At Birth? A Randomised Controlled Trial.
Funder
National Health and Medical Research Council
Funding Amount
$2,875,774.00
Summary
Premature babies under 30 weeks gestation are up to a hundred times more likely than full term babies to die or survive with major disability, often from brain damage due to poor blood flow after birth. This randomised study will find out if giving them more placental blood at birth, by means of a delay in clamping the umbilical cord, then milking it, reduces anemia, blood transfusions, brain damage, infection, death and disability. The results may benefit millions of premature babies worldwide.