A world-first trial of a maternal melatonin supplement may help improve outcomes for babies at risk of cerebral palsy and other neurodevelopmental disabilities.
The Protect-Me trial, conducted by Monash University, involves expecting mothers, whose babies show slowed growth in the second trimester, administering high doses of melatonin to test whether the cheap, over-the-counter supplement can protect these infants from poor neurological outcomes.
Lead researcher Dr Kirsten Palmer, Department of Obstetrics and Gynaecology at Monash University and Monash Health, says melatonin is a naturally occurring hormone that has been shown to have strong antioxidant effects and is capable of protecting the unborn baby's brain from harm, such as oxidative stress.
She says more than 330 pregnant women will be recruited across Melbourne, Brisbane and Auckland between 23 and 32 weeks gestation and will either take placebo or melatonin tablets three times a day until they give birth.
“We then follow the baby's neurodevelopment over their first two years of life. We hope to show that those exposed to melatonin during pregnancy are less likely to have complications with brain development than those exposed to placebo.”
Dr Palmer explains that although the trial may not provide direct benefit to currently expecting families due to its infancy, if successful the trial will change how 28,000 Australian families affected by fetal growth restriction are cared for each year.
“It would provide hope during those challenging weeks in a complex pregnancy that we have treatments available to help protect their baby prior to birth.
“It may also help to prevent up to 100 children around Australia every year being diagnosed with cerebral palsy as a direct result from fetal growth restriction.”
She says it is “hugely exciting” to see the culmination of over a decade of research lead to this world-first clinical trial.
“As a clinician, it is also really exciting to be exploring new ways to improve the care we can provide to women and their babies during these very complicated pregnancies,” Dr Palmer explains.
Senior Stem Cell Research Fellow at Cerebral Palsy Alliance Research Institute, Dr Megan Finch-Edmondson says over the past decade the rate of cerebral palsy in Australia has declined by 30 percent, indicating new preventive strategies are working and further progress is possible.
“The world-first trial of melatonin (the Protect-Me trial) is important because fetal growth restriction is a known risk factor for cerebral palsy that currently has very limited effective treatment options,” Dr Finch-Edmondson says.
“We are particularly excited about the launch of the Protect-Me trial since the Cerebral Palsy Alliance Research Foundation helped support this research through funding obtained from the Federal Minister for Health, the Hon Greg Hunt MP, through the Medical Research Future Fund.”
The trial research team includes Dr Kirsten Palmer (Principal Investigator/Obstetrician), Professor Euan Wallace (Obstetrician), Associate Professor Katie Groom (Obstetrician), Dr Miranda Davies-Tuck (Biostatistician), Professor Peter Anderson (Neurodevelopmental Psychologist), Professor Michael Fahey (Paediatric Neurologist), Professor Stacy Goergan (Radiologist) and Associate Professor Suzie Miller (Neurodevelopmental Physiologist).