A 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 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, 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.
He weighed 6lb 7oz but was unexpectedly born in a poor condition.
He was transferred to the hospital’s Neonatal Intensive Care Unit (Nicu) and put 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 hours after he was born.
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.
“This is the first time a cannabis-derived medicine has been tested intravenously in human babies.
“It is hoped that it will be good for preventing seizures and protecting the brains of new-born babies with HIE.
“We have always had good support from families wanting to take part in research on our Nicu and they often do it from an altruistic point of view to help benefit future babies.
“One of the attractions of this trial for parents is the closer brain monitoring that babies get as part of the study, because a more advanced brain wave monitor is used for the trial babies.
“This gives parents more reassurance that any seizures will be picked up.”
The first phase of the trial, involving units in the UK and Europe, will take around a year to complete.
“As with any study of a new medicine, there may be unexpected side effects and unknown risks,” said Prof Clarke.
“With this in mind, the trial has been carefully designed to make it as safe as possible and so we are only giving the babies a minuscule dose at the beginning and we monitor them even more closely than usual.”
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 therapeutic ingredient 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 after discharge 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.