Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Rutgers, The State University of New Jersey
24 participants
Feb 25, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
Exclusion Criteria1
- neonates without IVH grade 3/4 or older than 1 month.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06797219