A Norfolk newborn 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 is 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, buthis 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 ofepilepsy, and this is the first time it has been used to try to prevent seizuresin 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 lesseningthe 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.
He weighed 6lb 7oz but was unexpectedly born in a poor condition.
He was transferred to the hospital's Neonatal Intensive Care Unit (Nicu) andput into 72 hours of cooling treatment to protect his brain.
His whole body temperature was reduced to 33.5 degrees using a special jacket like a wine cooler.
He was also given a single intravenous dose of the drug, less than 12 hoursafter he was born.
The first babies on the study will receive a dose of 0.1 milligram perkilogram, which is a 30th of the normal dose.
Measurements of the electrical signals in Oscar's brain were taken for thefirst 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.
There are currently no approved drugs or medicinal therapies for HIE and the standard care is therapeutic hypothermia.
Participation in the trial is voluntary and the study drug's therapeuticingredient occurs naturally in the cannabis plant.
It is extracted under highly controlled conditions, ensuring that the THC(tetrahydrocannabinol) component, the chemical in cannabis that makes you high is minimal.
The research team will check at 30 days, six months and 12 months afterdischarge to check on the baby's development.
Miss Parodi said:
"I was approached after the birth about taking part in this study and I consulted my mum and my brother who is training to be a paramedic. "It was hard but I wanted to do everything I could to help my baby boy. "Oscar was in hospital for nine days and he was being monitored 24/7. "He is doing fantastically well and I am really grateful to Dr Clarke and the team for what they have done for us."
The study is funded and sponsored by GW Pharmaceuticals and is supported by the National Institute for Health Research.