Clinical Trial of Cannabidiol (CBD) in Newborns with Hypoxic-Ischemic Encephalopathy

Hypoxic-ischemic encephalopathy (HIE) is a type of brain damage caused by a disruption in the flow of oxygenated blood to the brain. One of the main populations that it affects is newborns who have experienced birth asphyxia (oxygen deprivation during or near the time of birth) (1). 

Currently, the most effective treatment for HIE is therapeutic hypothermia. When the brain is cooled in a controlled environment, a baby’s metabolism can slow just enough to allow brain cells more time to recover. This reduces the spread of brain damage, and improves long-term outcomes (2).

Nevertheless, therapeutic hypothermia should not be considered a cure; babies with HIE who undergo therapeutic hypothermia often still develop permanent disabilities such as cerebral palsy. Therefore, research into additional treatments for babies with HIE is critically important.

One potential avenue for treating neonatal HIE is cannabidiol, abbreviated CBD. 

What is cannabidiol (CBD)?

Cannabidiol is a compound found in the cannabis (marijuana) plant. Unlike tetrahydrocannabinol (THC), CBD does not cause the user to become “high.” The lack of mind-altering effects, combined with certain medicinal properties, has made CBD a popular treatment option for a wide variety of conditions. Recently, there has been a great deal of research into CBD as a neuroprotective agent. Studies have investigated its use in preventing or managing the effects of conditions such as epilepsy, multiple sclerosis, Parkinson’s, and Alzheimer’s (3). 

How could cannabidiol help babies with HIE?

Research has shown that cannabidiol can reduce neuro-inflammation, minimize damage from oxidative stress, and reduce glutamate-related excitotoxicity. These three factors are all considered to be major causes of brain damage. 

However, it has been difficult for researchers to do clinical tests on the use of CBD in infants. Dr. José Antonio Martínez-Orgado, head of the Neonatology Division at San Carlos Hospital in Madrid, told Project CBD that this may be because people associate CBD with recreational cannabis. “We have been asked to give a substantial amount of evidence of efficacy and safety for CBD treatment that for other treatments has not been required,” he said (4).

Despite this challenge, research on CBD as a treatment for neonatal HIE has recently been approved for a clinical trial. In large part, this is thanks to a preclinical trial (5) done by Lorena Barata and colleagues (including Martínez-Orgado). Their study subjects were day-old piglets with hypoxic-ischemic injuries. Some of the piglets were given therapeutic hypothermia, while others had normothermia. Additionally, some were given cannabidiol, while others had a vehicle treatment (i.e. a placebo administered in the same way). Barata et al. also had a group of untreated piglets to serve as a control. 

They found that cannabidiol offered some neuroprotection, especially when used in combination with therapeutic hypothermia; the two treatments acting together were much more effective than either treatment alone. 

“When we used them together, they were reducing brain damage by almost 100%,” Martínez-Orgado told Project CBD.

Project CBD reports that GW Pharmaceuticals is now backing a clinical trial (in Spain and the United Kingdom) on CBD in brain-injured newborns. The trial will use the same intravenous administration method used on the piglets. Babies will be divided into three groups:

  • Therapeutic hypothermia alone
  • Therapeutic hypothermia with CBD
  • Therapeutic hypothermia with a placebo

The CBD will be carefully purified, to avoid potentially harmful effects of other cannabinoids when given intravenously. 

Martínez-Orgado discussed certain factors which will make this study more unpredictable than research in a preclinical setting. In particular, because the piglets were given hypoxic-ischemic injuries for the purpose of the study, the researchers knew exactly when the oxygen deprivation occurred. However, with human babies, the exact timing of injury may be less clear (4). 

Nevertheless, this treatment holds a lot of potential. And unlike therapeutic hypothermia, which is most effective when given within the first six hours of life, the window for treatment with CBD may be a bit wider; a previous study on mice found neuroprotective effects when given up to 24 hours after the injury (6). 

Related reading

About ABC Law Centers: legal help for children with HIE and other birth injuries

ABC Law Centers was established to focus exclusively on birth injury cases. A “birth injury” is any type of harm to a baby that occurs just before, during, or after birth. This includes issues such as hypoxic-ischemic encephalopathy (HIE), infection, and trauma. While some children with birth injuries make a complete recovery, others develop lifelong conditions such as cerebral palsy and intellectual disabilities.

If a birth injury/subsequent disability could have been prevented with proper care, then it constitutes medical malpractice. Settlements from birth injury cases can cover the costs of lifelong treatment, care, educational resources, and more.

If you believe you may have a birth injury case for your child, please contact us today to learn more. We are happy to talk to you free of any obligation or charge. In fact, clients pay nothing throughout the entire legal process unless we win.

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Sources

  1. Hypoxic-Ischemic Encephalopathy Lawyers | ABC Law Centers. (n.d.). Retrieved June 25, 2019, from https://www.abclawcenters.com/practice-areas/prenatal-birth-injuries/fetus-or-newborn-medical-problems/hypoxic-ischemic-encephalopathy/ 
  2. Hypothermia Therapy | Treatment for Hypoxic-Ischemic Encephalopathy. (n.d.). Retrieved June 25, 2019, from https://www.abclawcenters.com/practice-areas/treatments-and-therapies-for-birth-injuries/hypothermia-cooling/ 
  3. 7 Benefits and Uses of CBD Oil (Plus Side Effects). (n.d.). Retrieved June 25, 2019, from https://www.healthline.com/nutrition/cbd-oil-benefits 
  4. CBD for Brain-Damaged Babies? (2019, June 17). Retrieved June 25, 2019, from https://www.projectcbd.org/medicine/cbd-brain-damaged-babies 
  5. Barata, L., Arruza, L., Rodríguez, M. J., Aleo, E., Vierge, E., Criado, E., … & Hind, W. (2019). Neuroprotection by cannabidiol and hypothermia in a piglet model of newborn hypoxic-ischemic brain damage. Neuropharmacology, 146, 1-11. 
  6. Mohammed, N., Ceprian, M., Jimenez, L., Ruth Pazos, M., & Martínez-Orgado, J. (2017). Neuroprotective effects of cannabidiol in hypoxic ischemic insult. The therapeutic window in newborn mice. CNS & Neurological Disorders-Drug Targets (Formerly Current Drug Targets-CNS & Neurological Disorders), 16(1), 102-108. 

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