A baby was delivered by emergency caesarean section at a Norwich hospital in March. The same baby became the first baby to join a cannabis treatment trial. The trial aiming at finding out if cannabis medicine are efficient in helping babies at risk of seizures and brain injury.
Oscar Parodi, was born, on 11 March in Norfolk, and encountered difficulties. “The baby was diagnosed with neonatal hypoxic-ischemic encephalopathy (HIE), a condition caused by a lack of oxygen or blood flow from the placenta to the developing baby.” He was then transferred to the neonatal intensive care unit, where he received cooling therapy for 72 hours.
What is HIE and the cooling treatment?
Cooling therapy is the only treatment for HIE in conventional medicine. Researchers believe that medicinal cannabis can be beneficial as protection. It might be useful for babies that are suffering from bran injury or seizures.
Babies that are diagnosed with HIE have higher risks of brain injury. Oscar’s mother was happy to participate in the trial program at the hospital. She accepted because it is a way to perfect cannabis derived medicine and do the most she can for her son. Also to see if it is efficient in dealing with neonatal care in babies with seizures and brain injury.
“Participating patients will be given a dose of either the trial medication, or a placebo, as soon as possible following birth. In addition, the babies also receive routine HIE cooling therapy to bring their body temperature down to 33.5C.”
“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 newborn babies with HIE.” said Prof Paul Clarke, a consultant neonatologist at NNUH, to The Guardian.
“We have always had good support from families wanting to take part in research on our [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 babies get as part of the study, because a more advanced brainwave monitor is used for the trial babies. This gives parents more reassurance that any seizures will be picked up.”
The clinical trial is progressing
Along with Oscar, there is another baby that was born in April which is participating in the trial too. The babies that participate are receiving the standard cooling therapy. Along with that, a single dose of the study drug or placebo followed by blood tests. Babies that are taking part in the trial receive only a 30th of the usual dose to minimize the risks. Furthermore, a single dose or a placebo was gave to them as soon as possible withing 12 hours of birth.
The producing process of the drug is under controlled conditions to ensure that the amount of THC, the psychoactive substance, is minimal.
Prof. Paul Clarke concluded saying: “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.”