Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Start Date
2/25/2025
Completion Date
7/31/2028
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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
Conditions
Locations
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey 07103
United States
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States