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Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Who can join
0 Days – 1 Month · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity (device)
Sponsor: Rutgers, The State University of New Jersey · Participants: 24 · Started: Feb 25, 2025
Contact the study team
- Garrett Gianneschi, Medical · Phone: 908-294-1161
- Onajovwe Fofah, Medical · Phone: 973-972-6753
Official record on ClinicalTrials.gov — NCT06797219
Locations in the U.S.
| New Jersey | Newark Beth Israel Medical Center, Newark Rutgers - New Jersey Medical School / University Hospital, Newark |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.