A landmark study on the benefits of deferred cord clamping for premature babies is named trial of the year.
Sydney Local Health District is committed to leading the way in discovering and implementing new treatments and technologies to meet the challenges we face in overcoming disease, reducing health disparities and meeting the needs and expectations of our communities.
In 2018 there are 550 active clinical trials across the District. Each is helping to advance clinical practice and save or improve the lives of our patients.
The Clinical Trial of the Year Award has been established to recognise and celebrate the outstanding achievements of Sydney Local Health District staff in the field of research. The Award comes with a $10,000 prize.
The 2018 Clinical Trial of the Year Award went to the Australian Placental Transfusion Study (APTS).
RPA Senior Staff Specialist neonatologists Associate Professor David Osborn and Associate Professor Nick Evans were key members of the team that designed and led the APTS.
Following the birth of very premature babies, standard practice is to cut the umbilical cord immediately so medical staff can care for the mother and baby separately. Some studies had reported that waiting for 60 seconds before clamping the cord sends more blood to babies’ brains and other organs and allows time for babies to start breathing by themselves, avoiding invasive procedures, giving them a better start.
APTS aimed to find out whether immediate cord clamping (clamping within 10 seconds of delivery) or delayed cord clamping (waiting at least 60 seconds before clamping) is better for premature babies in the short and long term. The study was the largest ever randomised controlled trial of delayed cord clamping for premature infants.
Researchers across 25 hospitals in seven countries enrolled 1,634 foetuses from women who were expected to deliver before 30 weeks of gestation, of which 1,566 were born alive before 30 weeks.
The main measurement for this study is the number of babies who survived without major complications to 36 weeks post-menstrual age – close to the time a full-term baby is born. In this study, “major complications” included serious health conditions affecting babies’ brains, eyes or intestines, and infections. No difference was found between immediate and delayed clamping.
However, the study found that delayed clamping might reduce the number of premature babies who die before 36 weeks post-menstrual age. The researchers also reviewed all the relevant studies of delayed cord clamping in premature infants. When they analysed all these trials together in nearly 3,000 babies, they found clear evidence that delayed clamping increased the number of babies who survived to leave hospital by about 30 per cent. They also found that delayed clamping is safe for mothers and premature infants.
The results when all the babies have reached 2 years corrected age are still to come. Researchers will then know whether deferred cord clamping has a lasting benefit for premature babies.
The study and the systematic review of APTS and other studies are published in The New England Journal of Medicine and The American Journal of Obstetricsand Gynecology.
The multicentre trial is coordinated by the NHMRC Clinical Trials Centre and is sponsored by University of Sydney. Funding has been provided by the National Health and Medical Research Council (NHMRC) of Australia.
The trial was awarded Clinical Trial of the Year by Federal Health Minister, Greg Hunt MP and the Australian Clinical Trials Alliance in May 2018.
The Excellence in Clinical Trial Support Award was established to recognise and celebrate the outstanding achievements of staff supporting clinical trial activity in the District. The Award carries a prize of $2000.
The 2018 Excellence in Clinical Trial Support Award went to Virginia Turner.
Ms Turner is the Manager of the Research Office at Concord Hospital. With more than 15 years of service to Concord’s Research Ethics and Governance office, Ms Turner leads her team in providing support and guidance for clinical trial ethics and governance issues.
Ms Turner provides advice on a range of matters, including queries on legal and regulatory requirements. Her guidance and support ensure that clinical trials are conducted according to regulatory and international standards.
An award for Special Merit: Clinical Trial Support was presented to Barbara Charlton with a $1000 prize.
Ms Charlton commenced in her role as a clinical trial nurse 18 years ago. Ms Charlton has worked in a wide variety of hepatology-related studies and her diligence, reliability and commitment to her role is highly regarded by her colleagues, investigators, study sponsors and patients. Over the last 10 years Ms Charlton has become increasingly involved in complex liver cancer studies. This is an exciting but difficult area to work in as patients involved in the study are often pursuing their only and final treatment option.
Ms Charlton’s experience in her role encompasses all aspects of clinical trial management, ethics and governance. She always puts the needs of her patients first and is compassionate, kind and understanding as they navigate their very difficult cancer journey. She has an expert level of knowledge and is always willing to assist and mentor new staff that come through the department.