A groundbreaking new trial in the United Kingdom has recruited a newborn baby to be given cannabis-derived medicines to help reduce the impact of seizures and brain damage.
A newborn in the United Kingdom, named Oscar Parodi, born at Norfolk and Norwich University Hospital via a Caesarian section, has just become the first baby in the world to join a cannabis-derived treatment trial to treat his rare condition.
Oscar's condition is called neonatal hypoxic-ischemic encephalopathy (HIE), and occurs because of oxygen deprivation to the brain, also commonly known as intrapartum asphyxia. The condition impacts roughly 1.5 babies per 1,000 births.
In Oscar's case, he was born prematurely and had to be transferred to the neonatal intensive care unit, where he was given cooling therapy for 72 hours. As such, he is the first baby to participate in a trial that will administer a high-CBD cannabinoid medicine intravenously within 12 hours of birth.
When speaking on Oscar's participation in the cannabis trial, his mother, Chelsea Parodi, from Watton, Norfolk, said: "I was approached after the birth about taking part in this study and I consulted my mum and my brother who is training to be a paramedic. It was hard but I wanted to do everything I could to help my baby boy. Oscar was in hospital for nine days and he was being monitored 24/7." Parodi stated that her son was "doing fantastically well".
The study is designed to determine whether cannabis-derived medicines are safe and effective in lessening the degree of brain injury for babies HIE.
Prof Paul Clarke, a consultant neonatologist at the hospital involved stated that there was great anticipation surrounding the trial within the neonatal intensive care unit: "This is the first time a cannabis-derived medicine has been tested intravenously in human babies. It is hoped that it will be good for preventing seizures and protecting the brains of newborn babies with HIE."
"We have always had good support from families wanting to take part in research on our [unit] and they often do it from an altruistic point of view to help benefit future babies. One of the attractions of this trial for parents is the closer brain monitoring babies get as part of the study, because a more advanced brainwave monitor is used for the trial babies. This gives parents more reassurance that any seizures will be picked up."
Another child within the hospital is included in the trial, and will receive either a single dose of the study drug, or a placebo, followed by rigorous testing to ensure their wellbeing is maintained. The dose of cannabis medicine involved in the baby trial will be a 30th of what is typically administered and will take up to a year to complete.
Professor Clarke concluded: "As with any study of new medicine, there may be unexpected side effects and unknown risks. With this in mind, the trial has been carefully designed to make it as safe as possible, and so we are only giving the babies a minuscule dose at the beginning, and we monitor them even more closely than usual."
The study is being carried out using medicine provided by GW Pharmaceuticals.
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