NCT06797219

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 0 Days – 1 Month
• Healthy volunteers: Not accepted

Summary

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. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.

Conditions

• Intraventricular Hemorrhage of Prematurity
• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity	The experimental arm will be administered treated with the study device. It will be 10 mW/cm\^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.

Timeline

• Start date: 2025-02-25
• Primary completion: 2027-07-01
• Completion: 2028-07-31
• First posted: 2025-01-28
• Last updated: 2025-07-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study