When a baby is born, all parents hope for a healthy child—all ten fingers and toes, a strong heart, and an able body. However, between 10 and 15 percent of babies born within the U.S. require special care within the NICU (Neonatal Intensive Care Unit), which is where preterm or diseased babies are cared for.
This time is crucial for babies; it's the stage in which we, as humans, are most sensitive. After the first hour of life, newborns should receive eye care, vitamin K, and recommended immunizations (birth dose of OPV and Hepatitis B vaccine). They should be assessed for birth weight, fetal age, congenital disabilities, and newborn illness signs. Special care is provided for sick newborns, preterm and/or low birth weight, and babies exposed or infected by HIV or have congenital syphilis.
One of the more common diseases for premature babies is jaundice, which refers to the yellowish discoloration of the skin, sclerae, and mucous membranes caused by an increase in bilirubin in the blood. This substance derives from the metabolism of hemoglobin contained in red blood cells. For the newborn, it is (in most cases) destined to disappear within a few days.
Jaundice becomes evident when the amount of bilirubin exceeds 3 mg per deciliter. The yellowish color occurs first in the face and sclerae (the white part of the eye) and then extends to the trunk and upper and lower limbs. Jaundice can be physiological or indicate a pathology.
However, jaundice can become severe. This happens when it goes untreated for too long, it can cause a condition called kernicterus. Kernicterus is a type of brain damage resulting from high levels of bilirubin in a baby's blood. It can cause cerebral palsy and hearing loss.
Babies are naturally sensitive, and premature newborns are even more at risk. Their immune systems are still developing due to being born prematurely, which increases their risk of getting sick. Skin conditions of many kinds are common; in addition to jaundice, many experience feeding issues, and fever (always the first sign of an infection).
Due to the nature of premature babies, it's essential to consider a non-invasive, non-medical treatment. They're still growing, just fully coming into their own and catching up on time missed developing in mom’s belly.
Light therapy is an incredible tool for these little humans, working inward and targeting the cellular level. It helps with both external and internal problems, which means that at the cellular level, light therapy alters and enhances the cell constitution. This, as a result, leads to faster and better reproduction, creating a healthier and stronger organism and body to function with.
Light therapy is a non-invasive, non-pharmaceutical form of therapy. The way it can help with neonatal care is unique. During treatments, the babies are completely safe and protected, with their eyes covered. The skin gets exposed to the light therapy lamp to absorb its benefits. The lamp is positioned specifically for the baby, no closer than 30.5cm.
Light therapy has successfully treated newborn jaundice by lowering the bilirubin levels in the baby's blood through a process called photo-oxidation. Photo-oxidation adds oxygen to the bilirubin, making it dissolve in water easily.
Since light therapy also helps to regulate circadian rhythm and melatonin, the treatments can also help babies sleep, which is essential in their healing and development.
You can customize and completely control light therapy consumption for babies, thanks to Kaiyan Medical’s state-of-the-art light therapy device manufacturing services. We have been working for 15 years to produce the best light therapy products on the market which are MDASAP-certified and FDA-approved light therapy devices, many of which are cleared for at-home treatments. Of course, before using a light therapy device, always consult your doctor. Contact our team for more information.
You want your baby to start living healthy and happy. However, things happen, and your baby can potentially become sick. Jaundice is one of the most common conditions that affect newborn babies, and it’s estimated 6 out of every 10 babies develop jaundice.
Jaundice is usually a harmless condition in newborns that causes yellowing of the skin and the whites of the eyes. This condition occurs when there’s a build-up of bilirubin in the blood. Biliburn is a yellow substance produced during the normal breakdown process of the red blood cells. The liver removes bilirubin from the blood in children and adults, passing it through the bowels and exiting the body.
However, a newborn baby’s liver cannot remove bilirubin as easily as an adult. This can create a build-up of bilirubin if the newborn has problems processing it and passing it through the body.
While most jaundice cases go away on their own, some newborns need help to lower bilirubin levels in the body.
Jaundice can occur in a newborn for different reasons:
Doctors can easily spot a baby with jaundice based on the yellowing of the skin and the whites of their eyes. Typically, newborns are checked for jaundice prior to leaving the hospital.
Babies who contract jaundice undergo blood tests to check for bilirubin levels. High levels of bilirubin have the potential to become serious.
Most cases of jaundice disappear within a week or two of treatment. However, some cases are quite serious and need to undergo treatment.
Light treatment aids with eliminating bilirubin in the blood. The baby’s skin absorbs the wavelengths, altering bilirubin which can pass easily through their bowels.
Phototherapy treatment has long been used to treat jaundice, with a row of lights or a spotlight directed at the undressed newborn from a healthy distance. Two soft eye patches are applied over the eyes for protection. Luckily, today’s technology of phototherapy can deliver effective treatment without any of the former inconveniences.
Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.
The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.
Device trials are unique.
Background of medical issue, the study goals, and why this study will further the science.
Should include:
Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria
Should evaluate the safety and effectiveness of the device in the population expected to be indicated.
Driven by either:
The minimum number of patients and/or minimum duration of follow-up may be required depending on:
Generally used to evaluate additional meaningful claims.
One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.
Lack of sleep is a villain in America and Europe. Light intake is a big part of the problem. Over 65% of adults say they don’t get enough good sleep every week. Most people also don’t get nearly enough natural light for optimal health: the average American spends over 90% of their time indoors.
In addition to not getting enough natural light, people today are surrounded by artificial blue light from screens and overhead lighting. An overload of artificial blue light can cause headaches and make it harder to get to sleep and stay asleep. When we take in all that bright blue light from laptops, TVs, and phones, especially before we go to bed, our bodies get the signal that it's time to be awake, even if we're tired.
Melatonin is the naturally-occurring hormone that regulates sleep and wakefulness. Emerging research is showing that red light therapy treatments can help people produce more of their own, natural melatonin than exposure to other light sources like blue light. Red light therapy is natural light. It’s much less bright than blue light, with a lower color temperature than daytime sun, as the image above shows. Research has shown that red light doesn’t upset your sleep cycle like bright blue light. Red light therapy is showing great clinical results for people with insomnia and sleep disorders.
The light therapy is a simple, non-invasive treatment that delivers concentrated natural light to your skin and cells. Clinical research is showing that red light therapy can improve sleep quality and duration, and help people produce more of their own melatonin.
Light plays a major role in your sleep cycle. The body’s circadian clock interprets light as a sign of when to sleep and when to be awake. Artificial blue light from phones, computers, and other screens is extremely bright and can knock your circadian rhythm out of whack. Red light has the opposite effect: it’s ideal for evenings because it has a low color temperature—far lower than blue light and much closer to the natural sunset.
Red light therapy treatments are quick and simple: you just sit or stand in natural light for 5 to 15 minutes, ideally every day. This stimulates your mitochondria and gives your cells the natural light they need to make energy.
Natural light is a key ingredient for a healthy circadian rhythm and restful sleep. If you struggle to sleep, your light intake could be a big factor. Red light therapy delivers natural light like you’d get from the sun, but without UV rays, excess heat, or the need for sunny weather.
Red light therapy treatments supercharge your cells with the natural light they need to make more core ATP (adenosine triphosphate) energy. This helps your body run more efficiently, heal faster, and has shown great results for producing more natural melatonin and improving sleep disorders like insomnia.
Red light therapy treatments have shown great sleep results in a range of peer-reviewed clinical studies. One study on the sleep of pro basketball players showed that a 2-week course of red light therapy in the evening improved players’ sleep quality in the short term. Based on the results, the researchers suggested red light therapy would be a good non-invasive, drug-free solution to sleep struggles.
Kaiyan's light therapy products are registered with the FDA as class II medical devices for the treatment of pain, strain, and inflammation. While the existing clinical research has been very positive for red light therapy and sleep, keep in mind that Kaiyan's devices are not cleared with the FDA for the treatment of various sleep disorders or melatonin.
Recent research on sleep disorders among people with migraine headaches has shown that red light therapy both decreased headache frequency, and was the only treatment that improved patients’ sleep disorders.
A 2014 study on cognitive function and traumatic brain injury (TBI) recorded that participants had significantly decreased episodes of post-traumatic stress disorder (PTSD), and improved sleep.
Analyzing patients’ electrical brain activity, a 2013 sleep study concluded that red light therapy was especially effective at helping people with sleep disorders fall asleep.
When I’m indoors training under the buzz of artificial lights, my body doesn’t get the natural light it needs. Add computers, cell phones, televisions, etc. and it’s easy to overload yourself with blue light. I used to have trouble sleeping after long training days, but since adding more natural light to my routine with red light therapy, I’ve been falling asleep as soon as I lie down, and I’ve been staying asleep all night.*
Sanne Wevers
Gold-Medal Winning Dutch Gymnast
Research is showing how closely mood and sleep disorders are interconnected. Parts of the brain that regulate sleep have also been found to closely affect mood. A 2013 review concluded that “nearly all people suffering from mood disorders have significant disruptions in circadian rhythms and the sleep/wake cycle.”
This Greatist post on natural light and serotonin gives good background on the connections between natural light intake, mental health, and sleep. It also mentions using Kaiyan's red light therapy devices to get more natural light, even when you can’t get more sunlight.
Trouble sleeping is one of the most common symptoms of seasonal affective disorder, a type of depression most common in the darker winter months. Some physicians treating patients with mental health disorders have said red light therapy both improves mood, and helps people with depression get better sleep.
Sources and References:
Morita T., Tokura H. “ Effects of lights of different color temperature on the nocturnal changes in core temperature and melatonin in humans” Journal of Physiological Anthropology. 1996, September
Lirong Z., Phyllis Z. “Circadian Rhythm Sleep Disorders” Neurologic Clinics. 2012, November.
Color Temperature
The State of Sleep Health in America.
Klepeis N., Nelson W., et al. “The National Human Activity Pattern Survey (NHAPS): a resource for assessing exposure to environmental pollutants”. Journal of Exposure Analysis and Environmental Epidemiology 2001.
Sheppard A and Wolffsohn J. “Digital eye strain: prevalence, measurement and amelioration.” BMJ Open Ophthalmology. 2018 April.
Gooley, J., Chamberlain, K., Smith, K., Khalsa, S., et al. “Exposure to Room Light before Bedtime Suppresses Melatonin Onset and Shortens Melatonin Duration in Humans” J Clin Endocrinol Metab. 2011 Mar.
Hamblin M. “Mechanisms and applications of the anti-inflammatory effects of photobiomodulation”. AIMS Biophys. 2017.
Zhao J., Tian Y., Nie J., Xu J., Liu D. “Red light and the sleep quality and endurance performance of Chinese female basketball players” Journal of Athletic Training. 2012, November-December.
Loeb LM, Amorim RP, et al. “Botulinum toxin A (BT-A) versus low-level laser therapy (LLLT) in chronic migraine treatment: a comparison.” Arquivos de neuro-psiquiatria. 2018 Oct;76(10):663-667.
Naeser MA, Zafonte R, et al. “Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study.” Journal of Neurotrauma. 2014 Jun 1;31(11):1008-17.
Wu JH, Chang YC. Effect of low-level laser stimulation on EEG power in normal subjects with closed eyes. Evidence Based Complementary and Alternative Medicine. 2013; 2013:476565.
Vadnie C, and McClung C. Circadian Rhythm Disturbances in Mood Disorders: Insights into the Role of the Suprachiasmatic Nucleus. Neural Plasticity. 2017 November.
McClung C. How might circadian rhythms control mood? Let me count the ways. Biological Psychiatry. 2013 April.
Nutt D, Wilson S, et al. Sleep disorders as core symptoms of depression. Dialogues in Clinical Neuroscience. 2008 September.
Avci P, Gupta A, et al. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Seminars in Cutaneous Medicine and Surgery. Mar 2013.
