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
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
A Randomised Controlled Trial Of Enhanced Parenting Capacity To Improve Developmental Outcomes In Preterm Infants
Funder
National Health and Medical Research Council
Funding Amount
$1,045,141.00
Summary
In Australia there are 2, 600 very preterm survivors each year. 50% will have education/behavioural difficulties and 10% major disability. We aim to optimise the development of infants born very preterm through a tailored Positive Parenting Program. We predict reductions in child behavioural and emotional problems at 2 years corrected age.
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.
Docosahexaenoic Acid For The Reduction Of Bronchopulomonary Dysplasia In Preterm Infants Born At Less Than 29 Weeks Gestational Age: A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$1,929,854.00
Summary
A major challenge in the care of very preterm babies, is dealing with the fact that the baby has very immature lungs. They are prone to an inflammatory condition known as BPD (broncho-pulmonary dysplasia) that prevents an infant from breathing, much like asthma in older children. This can result in poor health outcomes for life. Our study will test the effect of the omega 3 fat known as DHA in reducing this inflammation in the lung and result in better outcomes for the baby.
DHA For The Improvement Of Neurodevelopmental Outcome In Preterm Infants: The DINO Trial
Funder
National Health and Medical Research Council
Funding Amount
$631,875.00
Summary
The incidence of neurological problems that occur in children born prematurely is higher than for those born at term. The earlier that a baby is born, the greater chance it has of having some developmental delay and general inability to cope at school. This has implications for the child, the families and the health system. One of the many dietary factors implicated in the development of neural abilities in premature infants is an omega-3 fatty acid called DHA. This compound is present in breast ....The incidence of neurological problems that occur in children born prematurely is higher than for those born at term. The earlier that a baby is born, the greater chance it has of having some developmental delay and general inability to cope at school. This has implications for the child, the families and the health system. One of the many dietary factors implicated in the development of neural abilities in premature infants is an omega-3 fatty acid called DHA. This compound is present in breast milk and most preterm formulas and is found in high concentrations in the brain and retina. In the last third of pregnancy the developing baby would normally accumulate DHA at a rapid rate. So it seems reasonable to assume that a baby outside the mother, that is born premature, would also need to accumulate DHA at this same rate. The problem is that none of the milks currently given to premature infants have DHA in high enough concentration to supply this amount of DHA to the baby. For example, breast milk and preterm formulas contain only a third of the DHA required. In order to provide this amount for the premature infant, breast milk containing DHA at about 1% of the total fat is required. Fortunately the level of DHA in breast milk can be increased to this level by supplementing the mothers diet with fish or olis like tuna oil. This study hopes to show that premature babies who receive DHA in amounts similar to that supplied in the womb will develop better than babies who receive low amounts of DHA.Read moreRead less
Centre Of Research Excellence (CRE) In Newborn Medicine
Funder
National Health and Medical Research Council
Funding Amount
$2,622,320.00
Summary
Problems around birth are common and can have long-term implications, including into adulthood. Our goal is to improve health outcomes for all newborn babies and their families by determining factors that enhance outcome and assessing the benefits and consequences of new treatments for mothers and babies. We are world leaders in this field and are dedicated to training the next generation of health professionals in the care of newborn babies, in Australia and the rest of the world.
Retinal Photography To Assess Early Kidney Development In Indigenous Babies
Funder
National Health and Medical Research Council
Funding Amount
$888,098.00
Summary
The objective of this study is to identify infants who are at high risk off subsequent kidney failure . To achieve this objective, we plan to carry out comparison of kidney growth and function between Aboriginal and and non-Aboriginal infants from birth until they are 2 years old. We also hope to determine if changes in the blood vessels in these infants' eyes correspond to changes in the growing kidney- we are trying to determine if the eyes are the windows to the growing kidneys.