Can CBD help brain-damaged babies? A new clinical trial intends to determine.

The practice of administering medical cannabis to children is a difficult taboo to overcome, but new study is paving the way. The beginning of a clinical trial evaluating the use of CBD in neonates with hypoxic ischemic encephalopathy (brain damage caused by a lack of oxygen) is a new ray of hope for the more than one million infants born each year with this illness. Frequently, these infants are left severely crippled, and many of them die.

Asphyxia-induced hypoxic ischemic encephalopathy (HIE) is the greatest cause of infant mortality in the United States. Despite this, HIE is considered a rare disease because it affects just two or three neonates every thousand. HIE is caused by maternal diabetes, insufficient blood flow to the placenta, preeclampsia, congenital infections of the fetus, drug and alcohol addiction, and delivery problems. If HIE arises after birth, there is a heightened risk of mortality or impairment for premature infants.

Currently, the conventional treatment for severe HIE is hypothermia, which involves lowering the infant’s body temperature to 33-34°C. It has been discovered that hypothermia has neuroprotective effects, reducing brain inflammation, glutamate synthesis, and free radical generation. Hypothermia administered within six hours of delivery can avert death or serious impairment in 60% of cases.

Cannabinoids are viewed favorably by Spanish researchers. Can CBD help brain-damaged babies?

Prior to the discovery of hypothermia a few years ago, there was nothing that could be done, says Dr. José Antonio Martnez-Orgado, Associate Professor of Pediatrics and Chief of the Neonatology Division at the San Carlos Hospital in Madrid, Spain.

Dr. Martinez-Orgado told Project CBD, “It was a difficulty for me to be at the bedside of a very attractive, very good-looking infant who had some type of complication during delivery and was near to dying or had very, very significant brain damage.” We should take action.” Dr. Martinez-Orgado began his search for an adjuvant therapy to hypothermia that would improve the prognosis of these infants. The neuroprotective benefits of cannabis were repeatedly identified in preclinical research, thus he chose to examine their effects in animal models of HIE.

Martinez-Orgado and his team decided to focus on CBD rather than THC because the non-intoxicating cannabinoid lacked direct CB1 receptor activation, making it safer for developing brains. CBD consistently reduced neuro-inflammation, oxidative stress-induced damage, and glutamate-related excitotoxicity, which are considered the three leading causes of brain damage in individuals of all ages. In neonates, however, this trinity of events results in disproportionately severe brain damage compared to older children and adults.

This is why, according to Martinez-Orgado, it is so difficult to treat infants with brain injury, and why it is imperative to develop a treatment that acts on all three components simultaneously. This is CBD and it was hypothermia.”


Despite years of studies demonstrating CBD’s promise as an effective treatment for HIE, Spanish researchers have unable to advance to the clinical trial phase. Martinez-Orgado explains, “Perhaps because it’s viewed as cannabis, we’ve been asked to provide strong evidence of CBD’s efficacy and safety, although this was not required for other medicines.”

Can CBD help brain-damaged babies?

Nonetheless, the team’s most recent preclinical study proven to be a game-changer. The findings of testing CBD in conjunction with hypothermia on a piglet model of hypoxic-ischemic brain injury were astounding.

Three intravenous injections of pure CBD were administered to hypoxic-ischemic, insult-induced, neonatal piglets who had already experienced hypothermia.

“When administered combined,” Martinez-Orgado explains, “they reduced brain damage by over 100 percent.” Therefore, there was a significant synergistic impact, while hypothermia alone and CBD alone were ineffective. Together, CBD and hypothermia produced a tremendous neuroprotective effect.”


Can CBD help brain-damaged babies? Yes. As we can see, these promising results have opened the way for GW Pharma-backed stage II/III clinical trials to be conducted in hospitals across Spain and the United Kingdom this summer.

Using the same intravenous CBD administration mechanism, neonates with brain damage will receive hypothermia with CBD, hypothermia alone, or hypothermia with a placebo. Even minute levels of other cannabinoids or chemicals may not be tolerated when administered intravenously, therefore CBD will be thoroughly refined. While Martinez-Orgado is optimistic about the outcomes, he is aware that doctors will face several uncontrollable elements that were not present in the preclinical setting.

“When conducting preclinical experiments on animals,” he explains, “you know precisely when the hypoxic-ischemic insult takes place. And you precisely know how many minutes or hours after that you must begin treatment. The problem with human infants is that they are in the womb, and when the mother arrives at the hospital, we do not know when the hypoxic-ischemic damage began.

To further complicate matters, hypothermia must be administered within six hours of birth, giving doctors a very small window of chance. In a prior investigation on mice, CBD was found to be neuroprotective up to 24 hours following hypoxic-ischemic injury.


There is never a certainty that positive preclinical results will be duplicated in humans with adequate efficacy and safety for a medicine to be authorized. In this particular research trial, the team will need to wait 18 months following CBD administration to determine definitively whether the infants are free of long-term neurological impairment.

It is notable, however, that CBD has already reached this stage as a potentially life-saving treatment for the most vulnerable patient populations – a feat that demonstrates CBD’s potential as a safe and highly effective treatment for reducing the severe effects of brain injuries in patients of all ages.

Cannabinoids Garden