Actively Recruiting
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Led by Rutgers, The State University of New Jersey · Updated on 2025-07-22
24
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates with intraventricular hemorrhage grade 3 or 4
- Age less than 1 month
You will not qualify if you...
- Neonates without intraventricular hemorrhage grade 3 or 4
- Age older than 1 month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, United States, 07103
Actively Recruiting
2
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
Research Team
G
Garrett Gianneschi, Medical
CONTACT
O
Onajovwe Fofah, Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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