A world-first clinical trial led by Dr Kirsten Palmer and Professor Euan Wallace from the Department of Obstetrics and Gynaecology at Monash University and The Ritchie Centre at Hudson Institute will see women with fetal growth restriction (FGR) receive daily doses of melatonin to prevent poor neurological outcomes in babies.
In Australia, around 28,000 babies per year are born with fetal growth restriction – a condition where they stop growing in the womb, and are born very small. The most common cause of the disorder is from the placenta failing to deliver the amount of oxygen and nutrients required to meet the baby’s needs.
This oxygen deficiency results in oxidative stress, causing injury to the baby’s developing brain, often in the last few weeks before birth. This can lead to a number of undesirable outcomes including behavioural and cognitive impairment, cerebral palsy and stillbirth.
Dr Palmer says, “Oxidative stress happens in any cell when it’s deprived of oxygen, leading to a chain reaction of quite unhealthy changes in the cell.”
“We can see on ultrasounds that babies struggling in the womb start sending oxygen to their hearts and brains. It enables them to survive but it comes at the cost of increased risk of damage to the brain itself.”
Melatonin, which is a cheap, easily available supplement commonly used to combat jet lag, has potent antioxidant and anti-inflammatory properties.
“Melatonin is an antioxidant. It directly helps combat oxidative stress, but also helps to increase the cell’s underlying defence mechanisms,” Dr Palmer said.
In this first-in-human clinical trial in women between 23 and 32 weeks’ gestation will be voluntarily recruited through Monash Health and a number of major hospitals across Australia and New Zealand. They will receive either a melatonin tablet or a visually identical placebo tablet three times a day up until the birth of their baby.
The effectiveness in taking the melatonin will be determined by assessing whether the babies that were exposed to the supplement during pregnancy, have improved neurodevelopment at two years of age compared to those exposed to the placebo.
Given that melatonin is already on the market and has a great safety profile, using it as a treatment for growth-restricted babies could see rapid implementation into standard practice, should the trial prove successful.
“This is really exciting because it’s potentially the first treatment to give during pregnancy when a baby is developing to minimise the damage to the brain and give them the best chance of having completely normal development after birth.”
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