British Newborn Becomes First Baby to Join Cannabis Trial
Oscar Parodi, born March 11, is the world’s very first baby to become part of a cannabis-based treatment trial.
The trial will examine whether cannabis-derived medicine can be used safely and effectively in neonatal care to aid seizure- and injury-prone babies.
Oscar was delivered by emergency cesarean in March at Norfolk and Norwich university hospital (NNUH) in the UK. He was born with Neonatal Hypoxic-ischemic Encephalopathy (HIE) — a condition in which babies do not get enough oxygen or blood flow to the brain, potentially resulting in brain damage. Given his poor condition, Oscar was transferred to the neonatal intensive care unit for therapy.
His mother, Chelsea Parodi, said she was approached after the birth and offered to take part in the study. After consulting her mother and brother, who is a paramedic in training, she decided to accept. Even though it was a hard decision, she wanted to do everything she could to help her baby.
Another child, born in the same hospital in April, will also join the trail.
The subject of the study is a cannabis-based medicine that is already being used to treat children affected by rare forms of epilepsy. However, this is the first time it will be tested as a low-risk and functional treatment in lessening the degree of brain injury in infants born with HIE.
Prof Paul Clarke, a consultant neonatologist at NNUH, said that there is great promise in this study. He stated that one of the appeals for parents is the reassurance that “any seizures will be picked up” faster because of the more advanced brainwave monitor that is used for the babies in the trial.
The trial babies undergo standard cooling therapy for HIE, in which the whole body is cooled down to 92.3°F (33.5℃). They are also given a single dose of the study medicine or a placebo. The drug is administered intravenously as soon as possible within 12 hours of delivery.
The year-long study will involve other neonatal intensive care units across the UK and Europe.
The therapeutic ingredient in the study medicine occurs naturally in the cannabis plant. It is extracted under highly controlled conditions to make sure that the THC content, i.e., the psychoactive component of the plant, is minimal.
Last year, two cannabis-based drugs were greenlighted by the NHS in England for the treatment of epilepsy and spasticity in patients diagnosed with MS.
Prof Clarke added that side-effects and unknown risks are not uncommon in any study. To that end, the trail has been designed to be as safe as possible and the participants are only given a minimal dose of the medicine (i.e., a 30th of the usual dosage) in the beginning. On top of that, the babies are monitored more closely than usual.
Oscar Parodi was in the hospital for nine days where he was monitored 24/7. His mother says that “he is doing fantastically well.”