Light Therapy for Intraventricular Hemorrhage
(EFIL Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 650nm light therapy with irradiance of 10mW/cm2 for 5 minutes twice a day for 12 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including head circumference and neurodevelopmental outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Low Level Laser Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor