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
A Randomised Trial Of Constraint Induced Movement Therapy And Botulinum Toxin A In Children With Congenital Hemiplegia.
Funder
National Health and Medical Research Council
Funding Amount
$399,995.00
Summary
Congenital hemiplegia occurs in over 1 million children under 21 years of age in the industrialized world. It is the most common type of cerebral palsy, accounting for 36 percent of children diagnosed with this lifelong condition. We intend to determine if a promising new treatment approach is effective in providing a superior and lasting benefit, compared to conventional techniques. Children with hemiplegia usually have the intellectual capacity to attend normal school; however the impaired arm ....Congenital hemiplegia occurs in over 1 million children under 21 years of age in the industrialized world. It is the most common type of cerebral palsy, accounting for 36 percent of children diagnosed with this lifelong condition. We intend to determine if a promising new treatment approach is effective in providing a superior and lasting benefit, compared to conventional techniques. Children with hemiplegia usually have the intellectual capacity to attend normal school; however the impaired arm reduces independence in activities of daily living and can compromise their ability to participate in educational, leisure and vocational roles. Previously we have shown that a program of upper limb rehabilitation in children with spasticity was effective in improving participation and quality of life. We have also shown that rehabilitation combined with Botulinum toxin A (Botox) can further improve functional activity. We believe that a new method of therapy, that has been used effectively in Adults with stroke, called Constraint Induced Movement Therapy (CIMT) may also be beneficial in the treatment of children with congenital hemiplegia. In CIMT, the unimpaired arm is constrained in a glove to promote use of the impaired arm (hemiplegic arm). We predict that, combined with the Botox treatment, CIMT will provide a superior and longer lasting benefit compared to standard rehabilitation combined with Botox. The primary aim of our study is to test this hypothesis in a controlled trial. A secondary aim is to further our understanding of the central neurovascular mechanisms underlying changes in upper limb function. To achieve this, we will use Functional Magnetic Resonance Imaging (fMRI) and Transcranial Magnetic Stimulation (TMS) to measure central activation in the parts of the brain controlling movement. Improving our understanding of the mechanisms involved in this condition is an essential next step towards providing a more effective and long lasting treatment.Read moreRead less