Norwich hospital’s world first as baby has cannabis-based treatment to tackle brain injuries
PUBLISHED: 06:00 27 May 2020 | UPDATED: 12:05 27 May 2020
A Norfolk baby has become a “medical trailblazer” within hours of being born as he became the first in the world to sign up to a trial which could impact how brain injuries are treated at birth.
The Norfolk and Norwich University Hospital (NNUH)’s Neonatal Intensive Care Unit (NICU) are celebrating being part of a “world first” looking into the safety and effectiveness of a cannabis-derived medicine.
Oscar Parodi, from Watton, was born by an emergency caesarean on March 11, after his heart beat kept dropping. He is now one of two babies that have been enrolled by the hospital onto the randomised study.
The study will monitor if the medicine is safe and lessens the degree of brain injury for babies who are diagnosed with Neonatal Hypoxic-ischemic Encephalopathy (HIE) - which is caused by a lack of oxygen and/or blood flow getting to the baby from the placenta.
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Currently, there are no approved drugs or medicinal therapies for HIE and the standard of care is therapeutic hypothermia, which sees a baby cooled down to 33.5 degrees.
After he was born, Oscar transferred to the NICU where he was put on the cooling therapy for 72 hours.
His mum Chelsea was told about the trial and said while it was scary, it could make a difference to families in the future.
She 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.
“It was a little scary, it has never been done before and the risks that could come with that. I spoke to my brother and asked him and he said “do it.” “If it does help him, then it will help the research team and help other parents that need it.”
After nine days in NICU being monitored 24/seven, Miss Parodi was able to bring her son home for the first time. Due to HIE, she will need to monitor Oscar for seizures but said she would urge any parent to do the trial if they had the chance.
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She said: “He is doing fantastically well and I am really grateful to Dr Clarke and the team at NICU for what they have done for us.
I’ve very proud of how far he has come. It’s so nice to be able to hold him, and its wonderful to have him home and not hooked to wires.
“I will tell him he was the first baby to do this and show him how far its gone and how much of a difference it could make to babies.”
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The research, which involves a small number of babies from NICU wards in the UK and Europe will take around a year to complete. The drug is administered intravenously and the first babies to take part only receive a 30th of the usual dose.
The babies will continue to receive cooling treatment, as well as receiving either a single dose of the drug or a placebo. Following tests, the impact of the trial drug will be monitored by blood samples and measurements of the baby’s electrical signals in the brain.
The NICU team has worked with members of the hospital’s research and development, pharmacy and radiology team on the trial.
Professor Paul Clarke, consultant neonatologist at NNUH, said historically the hospital was not usually first to take part in the first phase of human studies in trials.
He said: “There is a lot of excitement on the unit and we are proud to have recruited the very first babies into this study.
“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.
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“As with any study of a new medicine, there may be unexpected side effects and unknown risks. 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.
“We are now keen to show we can embrace and deliver on these trials for the benefit of our current and future patients. Despite the pandemic, we have tried hard to continue doing this research trial over the past few weeks. Even though it is not a Covid-19- related study, we managed to keep this trial open for recruitment as we believe it is an important study which may help babies born with HIE.”
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