A British baby has become the first in the world to be given a cannabis-derived medicine as part of a new clinical trial to help infants born with a condition that can lead to brain damage.
Oscar Parodi was born at Norfolk and Norwich University Hospital with neonatal hypoxic-ischemic encephalopathy (HIE), which causes a lack of oxygen or blood flow from the placenta to the baby.
He received cooling treatment, as is standard for infants born with HIE, but his mother also agreed for him to be given a dose of the study’s cannabis-based drug as well.
The drug is already being used to help treat children with rare forms of epilepsy, and this is the first time it has been used to try to prevent seizures in a baby with HIE.
Researchers on the study, led by Guy’s and St Thomas’ NHS Foundation Trust in London, hope the drug could one day be used routinely in neonatal care to help babies at risk of seizures and brain injury.
The trial is looking to see if the medicine is safe and effective in lessening the degree of brain injury for those born with HIE.
Oscar’s 17-year-old mother Chelsea Parodi, a kitchen assistant from Watton in Norfolk, said she agreed for her son to be part of the study as she wanted to do everything she could to help him.
Oscar was born by emergency Caesarean on March 11 when he was three days overdue weighing 6lb 7oz .
The first babies on the study will receive a dose of 0.1 milligram per kilogram, which is a 30th of the normal dose.
Measurements of the electrical signals in Oscar’s brain were taken for the first 120 hours, as well as physical and neurological examinations and blood tests.
The Norfolk and Norwich University Hospital has enrolled the world’s first two babies onto the randomised study, in which they receive either a single dose of the study drug or a placebo.
Professor Paul Clarke, consultant neonatologist at the hospital, said: “There is a lot of excitement on the unit and we are proud to have recruited the very first babies into this study.
“It is hoped that it will be good for preventing seizures and protecting the brains of new-born babies with HIE.”
The first phase of the trial, involving units in the UK and Europe, will take around a year to complete.
There are currently no approved drugs or medicinal therapies for HIE and the standard care is therapeutic hypothermia.
The research team will check at 30 days, six months and 12 months after discharge to check on the baby’s development.