Light therapy for severe neonatal brain bleeding
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 0 Days to 1 Month |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Newark, New Jersey and 1 other locations) |
| Trial ID | NCT06797219 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are neonates under 1 month old diagnosed with intraventricular hemorrhage grade 3 or 4.
Not a fit: Patients without intraventricular hemorrhage or those older than 1 month will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for neonates suffering from severe brain bleeding.
How similar studies have performed: While this approach is novel, similar studies using light therapy for other conditions have shown promise, suggesting potential for success.
Eligibility criteria
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 this trial is running
Newark, New Jersey and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.