Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Recruiting now · Not applicable
Conditions studied: Intraventricular Hemorrhage of Prematurity, Hydrocephalus
In brief
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 facts
- Study ID
- NCT06797219
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 24
- Starts
- 2025-02-25
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2025-07-22
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
You may not qualify if…
- neonates without IVH grade 3/4 or older than 1 month.
Where it is running
- Rutgers - New Jersey Medical School / University Hospital — Newark, New Jersey, United States (enrolling)
- Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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