24 Participants Needed

Light Therapy for Intraventricular Hemorrhage

(EFIL Trial)

Recruiting at 1 trial location
OF
GG
Overseen ByGarrett Gianneschi, Medical
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a light therapy device to determine its safety and acceptability for treating severe intraventricular hemorrhage (a type of brain bleed) in newborns. The treatment uses a low-level laser therapy device twice daily for 12 days. Researchers will follow up with parents at 6 and 12 months to monitor their child's development. The trial seeks newborns less than one month old with severe intraventricular hemorrhage. As an unphased trial, it provides a unique opportunity for families to contribute to pioneering research that could enhance future treatments for newborns.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the EFIL device is safe for treating intraventricular hemorrhage in neonates?

Research shows that low-level laser therapy (LLLT) is usually well-tolerated by patients. Studies have found that it can improve brain function in people recovering from a stroke. No clear evidence links LLLT to serious side effects. However, since this trial is still in the early stages, complete safety information for using this treatment on newborns with brain bleeding is not yet available. The trial aims to gather more safety information, an important step in understanding the treatment's safety for newborns.12345

Why are researchers excited about this trial?

Low Level Laser Therapy (LLLT) is unique because it uses light to potentially treat intraventricular hemorrhage, a condition where bleeding occurs in the brain's ventricles. Unlike traditional treatments that often rely on medications or surgical interventions, this therapy involves a novel laser device that delivers a low-intensity laser beam directly to the affected area. Researchers are excited about this approach because it offers a non-invasive method that might reduce the risk associated with more invasive procedures. Additionally, the use of light therapy could stimulate cellular repair and reduce inflammation, offering a fresh hope for faster recovery.

What evidence suggests that the EFIL device is effective for intraventricular hemorrhage?

Studies have shown that low-level laser therapy (LLLT) can improve brain function in certain conditions. For instance, 70% of stroke patients who received LLLT showed positive results 90 days after treatment. Research with animals, such as rats, suggests that LLLT aids in brain recovery after injury. Other studies indicate that LLLT is safe and can positively affect brain function. This trial will investigate the effects of LLLT on intraventricular hemorrhage, using low-power lasers to promote healing and reduce damage, making it potentially beneficial for brain issues like bleeding in the brain.12467

Who Is on the Research Team?

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Onajovwe Fofah, Medical

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

This trial is for newborns with severe brain bleeding, known as Intraventricular Hemorrhage (IVH) grades 3 and 4. It aims to include about 12-24 infants who will receive a new light therapy treatment. Parents must consent to the study and agree to follow-up calls at 6 and 12 months for developmental tracking.

Inclusion Criteria

My newborn has a severe brain bleed and is under 1 month old.

Exclusion Criteria

My baby does not have severe brain bleeding and is older than 1 month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive 650nm light therapy with irradiance of 10mW/cm2 for 5 minutes twice a day for 12 days

12 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including head circumference and neurodevelopmental outcomes

4 months
Weekly head ultrasounds, phone surveys at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low Level Laser Therapy
Trial Overview The trial tests a Low Level Laser Therapy device called EFIL, which uses a specific red light on the babies' heads. The goal is to see if it's safe and feasible as a treatment option. Each baby gets this non-invasive treatment twice daily for twelve days.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Non-blinded, open label experimental armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Published Research Related to This Trial

Low-level laser therapy (LLLT) significantly improved neurological function in acute stroked rats, as observed in three laser-treated groups compared to a control group over 28 days.
The study involved 169 rats and demonstrated that LLLT applied at various locations on the brain can effectively enhance recovery from stroke-related deficits, suggesting its potential as a therapeutic intervention.
Transcranial application of low-energy laser irradiation improves neurological deficits in rats following acute stroke.Detaboada, L., Ilic, S., Leichliter-Martha, S., et al.[2015]
In a study of 73 patients with progressive angina pectoris, intracardiac irradiation of blood using a low-intensity Helium-Neon laser improved left ventricular pumping function compared to standard medication alone.
The laser treatment led to better intracardiac hemodynamics, including reduced blood volumes and increased left ventricular ejection fraction, likely due to its stabilizing effect on heart muscle contractility and its anti-ischemic properties.
[The intracardiac laser irradiation of the blood in correcting left ventricular dysfunction in progressive stenocardia].Sychev, OS., Tashchuk, VK., Luk'ianova, IS., et al.[2016]
Low-level laser therapy (LLLT) significantly reduces markers of muscle damage, such as lactate dehydrogenase (LD) and creatine kinase (CK), in rats with ischemic reperfusion injury, indicating its efficacy in protecting muscle tissue.
LLLT also promotes healing by decreasing muscle necrosis and atrophy while enhancing neovascularization, suggesting it could be a beneficial treatment for muscle injuries caused by ischemia.
Low-level laser therapy for protection against skeletal muscle damage after ischemia-reperfusion injury in rat hindlimbs.Lakyová, L., Toporcer, T., Tomečková, V., et al.[2015]

Citations

Transcranial Low-Level Laser (Light) Therapy for Brain InjuryThis significantly greater improvement was still present at 90 days poststroke, where 70% of the patients treated with Real LLLT had successful outcome, while ...
Study Details | NCT06797219 | Light Therapy Device for ...The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial ...
Light Therapy for Intraventricular Hemorrhage (EFIL Trial)Low-level laser therapy (LLLT) significantly improved neurological function in acute stroked rats, as observed in three laser-treated groups compared to a ...
Effect of Transcranial Low-Level Light Therapy vs Sham ...The results of this clinical trial show that transcranial LLLT is feasible, safe, and affects the brain in a measurable manner.
Transcranial low level laser (light) therapy for traumatic ...Several laboratories have shown that LLLT is effective in increasing neurological performance and memory and learning in mouse models of TBI. There have been ...
Light Therapy Device for Neonatal Intraventricular ...Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, ...
Safety Profile of Transcranial Near-Infrared Laser Therapy ...Intravenous administration of tPA, using an optimized dosing regimen, significantly increased hemorrhage incidence by 160%. The tPA-induced increase in ...
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