A two-month-old British baby has just become the world’s first infant to take part in a groundbreaking medical cannabis trial.
Oscar Parodi was delivered by an emergency cesarean section at Norfolk and Norwich University Hospital (NNUH) on March 11. Unfortunately, the baby was diagnosed with neonatal hypoxic-ischemic encephalopathy (HIE), a condition caused by a lack of oxygen or blood flow from the placenta to the developing baby. The newborn was transferred to the hospital's neonatal intensive care unit and was placed in cooling therapy for 72 hours.
Babies born with HIE are at elevated risk of suffering brain injuries, and the only currently available treatment for this condition is cooling therapy, in which the entire body is cooled down to 92.3 degrees. Traditional medicine has been ineffective at treating this condition, but neonatologists believe that medical cannabis could potentially protect babies from suffering seizures and brain injuries brought on by this condition.
Previous research has found that medical cannabis is highly effective at treating rare seizure disorders in children, and more recent studies are exploring the potential of CBD and other natural compounds to protect against brain injuries. The strength of this research has convinced NNUH to research the safety and efficacy of medical cannabis on infants born with HIE.
“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,” said the baby's mother, 17-year-old Chelsea Parodi, to The Guardian. “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.”
Babies participating in the trial will be given either an intravenous dose of plant-based medical cannabis or a placebo. Researchers selected a blend of cannabis oil with a low THC content, which will be administered at a dose of 0.1 milligram per kilogram, 1/30th of the adult dose. For the 120 hours immediately following the injection, doctors will carefully monitor the baby's vital signs. Each baby will receive only one dose of cannabis, and will also continue to receive cooling therapy during the trial.
“As with any study of a new medicine there may be unexpected side effects and unknown risks,” said Professor Paul Clarke, a consultant neonatologist at NNUH, to The Guardian. “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.”
It is unknown whether Oscar received the cannabis medicine or the placebo, but he has been “doing fantastically well” so far, according to his mother. Since Oscar's birth, the parents of a baby born at the hospital in April have also consented to allow their newborn to participate in the study.
“There is a lot of excitement on the unit and we are proud to have recruited the very first babies into this study,” Clarke told ITV. “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 new-born babies with HIE.”
"We have always had good support from families wanting to take part in research... and they often do it from an altruistic point of view to help benefit future babies,” Clarke added. “One of the attractions of this trial for parents is the closer brain monitoring that babies get as part of the study, because a more advanced brain wave monitor is used for the trial babies. This gives parents more reassurance that any seizures will be picked up."
Three years ago, this trial would have been completely illegal in the United Kingdom, but the Home Office finally legalized medical cannabis at the end of 2018. Britain's medical marijuana program is still in its infancy, but research studies like the NNUH study are certain to convince doctors of the healing properties of cannabis.