Pioneering research took place at Saint Mary’s Hospital. They trialed cannabidiol (CBD) – in conjunction with the NHS standard of care – as a potential treatment for newborns with moderate or severe brain injury.
Three babies born at Saint Mary’s – part ofManchester University NHS Foundation Trust (MFT)– were enrolled in the study, including Zahra Murangwa, born on 20 September 2021.Baby Zahra sustained oxygen loss at birth and was transferred to the Hospital’s Neonatal Intensive Care Unit (NICU) with a suspected brain injury or Hypoxic-ischemic Encephalopathy (HIE).Suppose a baby is diagnosed with moderate to severe HIE.
In that case, they will most likely be referred to a NICU to receive atreatment known as therapeutic hypothermia or ‘total body cooling therapy’. This is when a baby’s body temperature is lowered to 33.5 degrees Celsius, from the normal temperature of 37 degrees Celsius, to aid with the healing process of the baby’s brain.Until recently, there was no specific treatment for HIEother than intensive care support. However, several research studies have found that cooling a baby for 72 hours (three days) can limit the extent of brain injury in these babies who have suffered oxygen loss at birth.
About this research study
This study, ‘GWEP1560’ is an early phase, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacokinetics (how the medication is absorbed by and removed from the body) of the study medicine in newborns – in conjunction with the cooling treatment.
The study medicine is a standardized solution containing cannabidiol from the cannabis plant, extracted under highly controlled conditions to ensure it does not elicit a psychoactive response.
The study medicine or placebo is given over 15 minutes through an intravenous (IV) line already placed in the baby’s vein. This is delivered following the initiation of whole-body cooling and within 18 hours of birth.Dr. Ajit Mahaveer, Research Lead and Consultant Neonatologist at Saint Mary’s Hospital, is the study’s Principal Investigator at MFT.Dr. Mahaveer said: “Pre-clinical research has shown that cannabidiol (CBD) improved many of the damaging consequences of brain injury.
This clinical research has been undertaken as well as protective effects in both short-term and long-term administrations.”We are hugely grateful to all families who consented to their babies taking part in this study – during what we know is already a challenging time for them – as their participation could help us improve future outcomes for babies born with HIE.”I would also like to thank all our multidisciplinary study team members, who have worked extremely hard to ensure our Trust was the highest global recruiter to this study – underlining their commitment to our patients and families.”
The Murangwa family’s story
The Murangwa family lives in Salford, having moved to the UK from Uganda.Sibihwana said she had a normal pregnancy and then wasinduced at full-term (40 weeks) due to a slightlyelevated level of amniotic fluid, which is NHS standard of care if there is a risk to the baby.
“The birth was initially going well, but the baby was facing back-to-back and couldn’t come out. Due to her position and the prolonged labor, the decision was made for an emergency cesarean,” said Sibihwana.”After delivery, they found she had oxygen loss, couldn’t breathe adequately on her own, and had a seizure. The clinical team then managed to get her to breathe independently, and she didn’t need to be intubated, but she had to be taken to NICU because of a suspected brain injury.
While being cared for within the NICU at Saint Mary’s Hospital, baby Zahra received the 72-hour cooling treatment. During this time, Mr. and Mrs. Murangwa were approached by the research team about participating in the study.Sibihwana said: “The research team explained what the study would involve, and we consented to it – we had no problem with it. “We weren’t sure whether it would help Zahra directly or whether she would receive the placebo, but we were just happy for our daughter to participate.”It’s important to us; I wouldn’t want someone else to go through what we went through.
We agreed that If in any way we can help someone else go through this easier or quicker – or if we could help improve outcomes for other babies who have a similar injury – we’d be glad to take part in it.”We’ve been privileged for her to have the cooling treatment, even though it was distressing; that’s one of the reasons her life was saved. We don’t have access to cutting-edge treatment like this back home, and we feel fortunate.
“Zahra was discharged from Saint Mary’s Hospital after 10 days and is now at home with her family; For more than four months, Zahra has been doing well and hitting all her developmental milestones.Sibihwana said: “The NICU team were terrific, the research team were very helpful and explained everything well.
Her consultant, Dr. Mahaveer, took a moment to speak to us as we left the hospital, and he was very happy with how she was doing.”Zahra doesn’t seem to have a severe form of the injury. She hasn’t had any seizures since just after she was born. God willing, it will be a mild form and resolve completely on its own.”To us, she is perfect and everything we hoped she’d be.”