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Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Sponsor: Rutgers, The State University of New Jersey
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.
Key Details
Gender
All
Age Range
0 Days - 1 Month
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-02-25
Completion Date
2028-07-31
Last Updated
2025-07-22
Healthy Volunteers
No
Interventions
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.
Locations (2)
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States