Clinical trial Recruiting at 2 sites Interventional Ages 0 Days to 1 Month

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 typeInterventional
Ages0 Days to 1 Month
SexAll
Enrollment24 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Locations2 sites (Newark, New Jersey and 1 other locations)
StatusRecruiting
StartedFebruary 25, 2025
Main results expectedJuly 1, 2027
Study endsJuly 31, 2028
Registry record updatedJuly 22, 2025
Trial IDNCT06797219 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.