Norwich Hospital conducts European-wide trial using natural ingredients to help reduce the risk of seizures and brain damage
A newborn baby who arrived in an emergency Caesarean section in a hospital in Norwich in March has become the first baby in the world to participate in a cannabis-based treatment trial. This study is the first step in what 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 born on March 11 at the Norfolk and Norwich University Hospital (NNUH). He was born by accident 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 consulted with my mother and brother who is training as a paramedic. It was difficult but I wanted to do my best to help my little boy. Oscar was hospitalized for nine days and was watched 24 hours a day, 24 days a week. ” Parodi said his son "is doing wonderfully well." This study is examining whether the drug is safe and effective in reducing the degree of brain damage in babies with neonatal hypoxic ischemic encephalopathy (HIE).
Professor Paul Clarke, consultant neonatologist at NNUH, said that the neonatal intensive care unit was very enthusiastic. "This is the first time that a cannabis-derived drug 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 HSI. 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 the babies' brains as part of the study, as a more advanced brain wave monitor is used for the trial babies. Parents are thus more reassured that any crisis will be detected. ”A second child, born in April at the hospital, is also part of the plan. Children participating in the trial receive standard hypothermia IHE therapy, during which the whole body is cooled to 33,5C, as well as a single dose of the study drug or placebo, followed by a few controls to measure the levels of the drug in the blood.
Trial babies will receive a dose of the study drug, or a placebo, as soon as possible, within 12 hours of birth.The therapeutic component of the drug is naturally found in the cannabis plant and is extracted in 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 unanticipated side effects and unknown risks. This is why the test has been carefully designed to make it as secure as possible, we give babies only a tiny dose at first, and we monitor them even more closely than usual. ”