Norwich Hospital conducts European-wide trial using natural compounds to counter risk of seizures and brain damage
A newborn, who arrived on an emergency Caesarean section in March at a hospital in Norwich, has become the first baby in the world to participate in a cannabis-derived treatment trial. This study is the first step in what the researchers say may one day lead to the routine use of a cannabis-derived drug in neonatal care to help babies at risk for seizures and brain damage.
The baby, Oscar Parodi, was delivered on March 11 at Norfolk and Norwich University Hospital (NNUH). He was accidentally born in a worrying state of health and had to be transferred to the neonatal intensive care unit, where he received cold therapy for 72 hours. His mother, Chelsea Parodi, of Watton, in Norfolk, said “I was contacted after birth to participate in this study and I consulted with my mother and brother who is training as a paramedic. It was difficult but I wanted to do everything I could to help my little boy. Oscar was hospitalized for nine days and was monitored 24/24 ”. Parodi said her son was “doing wonderfully well.” This study examines whether the drug is safe and effective in reducing the degree of brain damage in babies with neonatal hypoxic ischemic encephalopathy (NEI).
Professor Paul Clarke, consultant neonatologist at NNUH, said that the neonatal intensive care unit was very enthusiastic. “This is the first time that a drug derived from cannabis has been tested intravenously on human babies. It is hoped that it will be beneficial in preventing seizures and protecting the brains of newborns with EHI. We have always been supported by families who wanted to participate in research on our [unit] and they often do so altruistically to help future babies. One of the interesting aspects of this trial for parents is the closer monitoring of babies' brains as part of the study, as a more advanced brain wave monitor is used for the babies in the trial. Parents are thus more reassured that any crisis will be detected. ”A second child, born in April in hospital, is also part of the system. Children in the trial receive standard IHE therapy with hypothermia, in which the entire body is cooled to 33,5C, as well as a single dose of the study drug or a placebo, followed by a few controls. to measure the levels of the drug in the blood.
Babies in the trial will receive a dose of study drug, or a placebo, as soon as possible within 12 hours of birth.The therapeutic component of the drug is found naturally in the cannabis plant and is extracted into highly controlled conditions to ensure that the level of tetrahydrocannabinol (THC) that causes a “high” is minimal.
Clarke added, “As with any study of a new drug, there may be unforeseen side effects and unknown risks. That's why the trial has been carefully designed to make it as safe as possible, we only give babies a tiny dose at first, and we monitor them even more closely than usual ”.