World-first for NNUH with neonatal cannabis-based medicine trial
Within hours of his birth, Oscar Parodi became a medical trailblazer.
After an emergency caesarean, Oscar became the first baby in the world to join a cannabis-derived medicine treatment trial, which is underway at the Neonatal Intensive Care Unit (NICU) at the Norfolk and Norwich University Hospital (NNUH).
Researchers say this world-first at NNUH is the first step that could one day lead to a cannabis-derived medicine being used routinely in neonatal care to help babies at risk of seizures and brain injury. This study is looking to see if the medicine is safe and effective in lessening the degree of brain injury for babies with Neonatal Hypoxic-ischemic Encephalopathy (HIE).
The NNUH has enrolled the world’s very first two babies onto the randomised study, which is funded and sponsored by GW Pharmaceuticals and is supported by the National Institute for Health Research (NIHR).
Professor Paul Clarke, Consultant Neonatologist at NNUH, said the hospital was “leading the way”, thanks to the efforts of staff on NICU, Research and Development, Pharmacy and Radiology at NNUH, and thanks to the support of parents and families.
“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.”
Babies who take part in the trial continue to receive standard hypothermia treatment for HIE where the whole body is cooled down to 33.5 degrees. They receive a single dose of the study drug or a placebo (dummy medicine) followed by some tests to measure levels of the drug in the blood.
Oscar was delivered by emergency caesarean section on 11 March. He was unexpectedly born in a poor condition and needed transfer to the Neonatal Intensive Care Unit (NICU) where he was put on the cooling therapy for 72 hours.
His mum Chelsea Parodi, of Watton, 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 number of babies involved is small for this first phase of the trial, which involves other NICUs in the UK and Europe and will take approximately one year to complete. The drug is administered intravenously and the first babies to take part only receive a 30th of the usual dose.
Prof Clarke added: “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.
“This research is a real team effort involving NICU, Pharmacy, Radiology, Research and Development and Digital Health and everyone is really proud to be part of it and to be involved in a world first.
Historically, our hospital has not usually taken part in phase 1 (first in human) studies, but 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.”
Notes to editors
Participation in this study is entirely voluntary by the parents/guardians/ legal representatives who are free to withdraw participation at any time.
Hypoxic-ischaemic encephalopathy (HIE) is caused by a lack of oxygen and/or blood flow getting to the baby from the placenta. There are currently no approved drugs or medicinal therapies for HIE and the standard of care is therapeutic hypothermia.
What is the study medicine? – The solution contains a cannabis based medicine in a formulation that will be administered intravenously. The therapeutic ingredient occurs naturally in the cannabis plant and is extracted under highly controlled conditions, ensuring the tetrahydrocannabinol (THC) component which causes a ‘high’ is minimal.
When is it administered? – Babies who take part will be given a single dose of study medication or a placebo as soon as possible after the start of whole-body hypothermia and within 12 hours of birth. The impact of the trial drug will be monitored by blood samples and measurements of the baby’s electrical signals in the brain. After leaving NICU, the research team will call 30 days, 6 months and 12 months after discharge from hospital.