Light therapy for severe neonatal brain bleeding
Official title: Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Run by Rutgers, The State University of New Jersey · NCT06797219 · Data updated 2026-11-12
This study is testing if a special light therapy can help newborns with severe brain bleeding feel better and develop normally over time.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 1 Month |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Newark, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | July 31, 2028 |
| Registry record updated | July 22, 2025 |
| Trial ID | NCT06797219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates under 1 month old diagnosed with intraventricular hemorrhage grade 3 or 4.
✕Probably not a fit
Patients without intraventricular hemorrhage or those older than 1 month will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study evaluates the feasibility of using a low-level laser therapy device to treat neonates with intraventricular hemorrhage grades 3 and 4. The intervention involves administering 650nm light at an irradiance of 10mW/cm2 for 5 minutes twice daily over a 12-day period. The study aims to assess safety, recruitment processes, parental acceptability, and retention rates, while also tracking developmental milestones at 6 and 12 months post-treatment. The findings will inform the design of a larger trial.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for neonates suffering from severe brain bleeding.
How similar studies have gone: While this approach is novel, similar studies using light therapy for other conditions have shown promise, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old. Exclusion Criteria: * neonates without IVH grade 3/4 or older than 1 month.
Where it's running
-
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, United States Recruiting -
Newark Beth Israel Medical Center
Newark, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Onajovwe Fofah, Medical — Rutgers, The State University of New Jersey
- Study coordinator: Garrett Gianneschi, Medical
- Email: garrettgianneschi@gmail.com
- Phone: 908-294-1161
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Wearable sensor to detect CSF flow in shunt tubing
This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.
-
CSF lactate and other biomarkers in patients with an external ventricular drain after acute brain injury
This project will test whether changes in cerebrospinal fluid lactate and other blood/CSF biomarkers can help detect ventriculostomy-associated infection in adults with acute brain injury who have an external ventricular drain.
-
See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep
A wireless thermal device is being tested to see if it can non-invasively monitor CSF shunt flow in people with hydrocephalus during everyday activities and sleep.
-
Evaluating a device for measuring cerebrospinal fluid flow and headaches
This study is testing a new device that measures the flow of cerebrospinal fluid in people with hydrocephalus to see if it can help understand their headaches better.
-
Understanding brain and heart injuries after bleeding in the brain
This study looks at how bleeding in the brain affects both the brain and the heart in adults to better understand the connection between these injuries.
-
Evaluating outcomes in neurosurgery using standardized measures
This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.