A British baby born in March in a Norwich hospital is currently participating in a clinical trial of a drug derived from cannabis, in what appears to be a world first.
The study is a first step towards the possible prescription of a cannabis-derived drug to help babies at risk of seizures and brain damage. It will determine whether the CBD drug, supplied by GW Pharmaceuticals, is safe and effective in reducing brain damage in babies with hypoxic-ischemic neonatal ischemic encephalopathy (HIE).
His mother, Chelsea Parodi explained that she was approached after the complicated birth of her son to participate in this study:
I consulted with my mother and my brother who is training to become an ambulance driver. It was difficult but I wanted to do everything I could to help my baby. Oscar was hospitalized for nine days and was monitored 24/7.
She also said that her son “was doing very well.”
Professor Paul Clarke, a neonatologist at Norwich Hospital, said there was a lot of excitement around the study.
This is the first time a drug derived from cannabis has been tested intravenously in human babies. It is hoped it will be good for preventing seizures and protecting the brains of newborns with EHI.
A second child born in April is also part of the trial. The children receive a standard treatment of hypothermia, where the entire body is cooled to 33.5°C, as well as a single dose of the study drug or placebo, followed by some tests to measure drug levels in the blood.
The trial, in which the drug is administered intravenously at one-thirtieth the usual dose, involves other neonatal intensive care units in the UK and elsewhere in Europe. It is expected to last one year.