Condition: Intraventricular Hemorrhage of Prematurity · Hydrocephalus · Sponsor: Rutgers, The State University of New Jersey
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.
This description comes directly from the study's public registry record.
Garrett Gianneschi, Medical · 908-294-1161 · garrettgianneschi@gmail.com
Onajovwe Fofah, Medical · 973-972-6753 · fofahon@njms.rutgers.edu
Always discuss trial participation with your own doctor first.
| Rutgers - New Jersey Medical School / University Hospital | Newark, New Jersey, United States | Recruiting |
| Newark Beth Israel Medical Center | Newark, New Jersey, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06797219