It may sound crazy--giving cannabis to infants--but ongoing research predicts that it may save babies' lives. The recent approval of a clinical trial to evaluate the use of CBD in the case of hypoxic-ischemic encephalopathy (HIE) in newborns shows that the pharmaceutical industry may be willing to get behind it. Hypoxic-ischemic encephalopathy, often called birth asphyxia, occurs inapproximately 2-9 babies per every 1,000 live births.
Although this number may not seem outstanding, HIE is documented as theleading cause of infant mortality in the United States and is recorded to affect an even higher number of children in countries where birthing resources are low. HIE is also a primary cause of other severe impairments, and the condition requires immediate care.
This clinical trial focuses on adding CBD alongside current standard treatments for the condition, and previous data collected by Spanish researchers suggests that the two treatments showsignificant synergistic effects, greatly reducing brain damage.
Hypoxic ischemic encephalopathy is characterized by a lack of oxygen and blood flow that causes cell death in parts of the brain. As cells die, they release material that is toxic to other brain cells, causing irreversible brain damage. In cases where HIE is untreated (and even after treatment in some cases), this birth injury can lead to other severe conditions, like organ dysfunction, cerebral palsy, or death.Factors leading to the condition vary but could include preeclampsia, cord compression, placental blood clots, near SIDS events, lack of blood circulating to the placenta, improper fetal position, medical malpractice, and more.
Currently, the standard treatment for HIE is therapeutic hypothermia, a method in which the body temperature is lowered significantly to achieve neuroprotective effects. This method is relatively new, and before it emerged there was no standard treatment for the condition, leaving many families to suffer. Still,therapeutic hypothermia has become widely accepted as the best treatment method available.
This treatment can be distributed to the baby in the form of whole-body cooling, or with a cooling cap, but is most effective only when distributed within 6 hours of the asphyxia-related injury. Often, the cooling time is suggested to be 72 hours. During that time, the lower body temperatures slow down the speed at which brain damage spreads, giving the cells more time to react and recuperate. This is referred to as a “neuroprotective effect” and it is the proposedneuroprotective effects of cannabinoids that made Spanish researchers curious about adding CBD to the mix.
Dr. Jose Antonio Martinez-Orgado, head of the Neonatology Division and Associate Professor of Pediatrics at San Carlos Hospital in Madrid, Spain, is no stranger to HIE, and knows that even with Therapeutic Hypothermia, many HIE affected babies suffer from lifelong disabilities. Seeing a need for new and improved treatment methods, he decided that cannabinoids could be a good fit, given their proposed neuroprotective properties. He and his colleagues settled on CBD due to its lack of psychoactive effects. Their research started with distributing CBD alone to hypoxic-ischemic brain-damaged piglets, and in many cases, cannabidiol displayed significant neuroprotective benefits in infant HIE.
Although they had consistently recorded overwhelmingly positive effects from CBD, red tape has kept them from entering clinical trials until this point. Still, the latestpreclinical trial brought more undeniable evidence to the table.
CBD, when extensively purified and intravenously injected after HIE affected piglets underwent hypothermia treatment, showed an ability to decrease permanent brain damage almost entirely. Researchers then identified the synergistic effect between the two treatment methods, noting that cannabidiol was well tolerated in piglet models. Plus, cannabidiol could be given at a much wider window than the standard 6 hours after birth suggested for hypothermia, leaving much more room for success if CBD for HIE passes clinical trials.
Now, the treatment method goes to clinical trials across hospitals in Spain and the UK. HIE affected babies will be given either standard therapeutic hypothermia treatment on its own, alongside the intravenous injection of highly purified CBD, or alongside a placebo.
Ultimately, it's impossible to know how this study will conclude, especially given the multiple varying factors. For instance, unlike in HIE-induced piglets, it’s impossible to pinpoint in most cases the exact moment when the asphyxia-related injury occurred in human infants. This varying factor is expected to alter the effects in some cases, but with the wider dosing window for CBD, it’s still reasonable to expect good results.
This isn’t the first time that CBD has been touted for its potential neuroprotective effects, and some research has focused on cannabidiol as a treatment method formany neurological disorders, like Parkinson’s Disease, multiple sclerosis, Alzheimer’s Disease, and more. However, this clinical trial still faces some opposition, as many are concerned about the use of cannabis-based medications on children.
However, this concern is unacquitted, as CBD has already been eyed as a treatment forchildhood epilepsy, Lennox-Gastaut syndrome, an incredibly rare and severe form of childhood epilepsy. In fact, one cannabinoid-based medication, Epidiolex, has been approved for the treatment of this condition.
In the trek to take CBD-based treatment for Hypoxic Ischemic Encephalopathy, Martinez-Orgado and his colleagues faced multiple legal obstacles. One issue was the difficulty in proving CBD’s safety profile, especially in the use of children, as the existing evidence is still slim. However,research that has aimed at proving the safety of CBD shows thatside effects are rare and that CBD is tolerated well in most cases. To date, no severe injury or death has been linked to pure, high-quality CBD, and even theWorld Health Organization has suggested that CBD poses no public threat.
If this CBD-based treatment method passes clinical trials, it likely will still face opposition because of its connection to cannabis. Still, this form of treatment could be life-changing for the many families affected by infant HIE every year. In the event that this treatment method becomes widely and readily available in NICU’s across the world, we could truly experience a pivotal moment for CBD and cannabis medicine.
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