British Baby First to Get New Cannabis Medicine
A British baby has become the first in the world to be given a cannabis-derived medicine to prevent seizures in infants with a condition that can lead to brain damage.
Oscar Parodi was born with neonatal hypoxic-ischemic encephalopathy (HIE), which is a lack of oxygen or blood flow from the placenta to the baby.
The baby, now 11-weeks-old, received cooling treatment at Norfolk and Norwich University Hospital, which is standard for infants born with HIE, but his mother also agreed he could be given a dose of the study's cannabis-based drug as well.
It is the first time the drug has been used to try to prevent seizures in a baby with HIE, and is already being used to help treat children with rare forms of epilepsy.
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 mother, Chelsea Parodi, 17, a kitchen assistant from Watton in Norfolk, 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 little boy was born by emergency Caesarean when he was three days overdue on 11 March, weighing 6lb 7oz but was unexpectedly born in a poor condition.
He was put into 72 hours of cooling treatment to protect his brain, using a special jacket like a wine cooler to get his body temperature down to 33.5C.
Less than 12 hours after he was born he was also given a single 0.1 milligram per kilogram intravenous dose of the cannabis-based drug - a 30th of the normal dose.
Doctors took measurements of the electrical signals in Oscar's brain for the first 120 hours, as well as physical and neurological examinations and blood tests.
The world's first two babies have been enrolled at Norfolk and Norwich University Hospital onto the randomized study, either receiving a single dose of the 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 (Neonatal Intensive Care Unit) 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 about a year to complete, with the babies' development being checked at 30 days, six months and 12 months after discharge.