A British baby has become the first in the world to receive a cannabis-derived drug to prevent seizures in infants with a condition that can cause brain damage.
Oscar Parodi was born with hypoxic-ischemic neonatal 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 therapy at Norfolk and Norwich University Hospital, which is the norm for infants born with HIE, but his mother also agreed that he could also receive a dose of the cannabis-based drug from the study.
This is the first time the drug has been used to try to prevent seizures in a baby with HIE and is already used to help treat children with rare epilepsy.
Researchers in the study, led by Guy’s and St Thomas ‘NHS Foundation Trust in London, hope the drug may someday be used regularly in neonatal care to help babies at risk for seizures and brain damage.
The trial is looking to see if the drug is safe and effective in reducing the degree of brain damage in people born with HIE.
Oscar’s mother, Chelsea Parodi, 17, a kitchen assistant from Watton in Norfolk, said, “I was approached after birth to participate in this study and consulted with my mother and brother who is in training to become a paramedic.
“It was difficult but I wanted to do everything I could to help my little boy.
“Oscar was hospitalized for nine days and was watched 24/7.
“He is doing very well and I am truly grateful to Dr. Clarke and the team for what they have done for us. “
The baby boy was born by emergency Cesarean section when he was three days late on March 11, weighing 6 lb 7 oz, but was unexpectedly born in poor condition.
He was subjected to a 72-hour cooling treatment to protect his brain, using a special jacket like a wine cooler to lower his body temperature to 33.5 ° C.
Less than 12 hours after birth, he also received a single intravenous dose of 0.1 milligrams per kilogram of cannabis drug – one 30th of the normal dose.
Doctors took measurements of electrical signals in Oscar’s brain for the first 120 hours, as well as physical and neurological exams and blood tests.
The world’s first two babies were enrolled in Norfolk and Norwich University Hospital for the randomized study, receiving either a single dose of the drug or a placebo.
Professor Paul Clarke, consultant neonatologist at the hospital, said, “There is a lot of excitement in the unit and we are proud to have recruited the very first babies in this study.
“This is the first time that a cannabis-derived drug has been tested intravenously in human babies.
“We hope it will be good for preventing seizures and protecting the brains of newborns with HIE.
“We have always received good support from families wishing to participate in research on our Nicu (neonatal intensive care unit) and they often do so from an altruistic perspective to help future babies.
“One of the attractions of this trial for parents is the closer brain monitoring that the babies get as part of the study, because a more advanced brain wave monitor is used for the test babies.
“It reassures parents more about the seizure of any seizure. “
The first phase of the trial, involving units in the UK and Europe, will take around a year, with babies’ development being monitored 30 days, six months and 12 months after discharge.