Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.

Locations
United States
New Jersey
Newark Beth Israel Medical Center
RECRUITING
Newark
Rutgers - New Jersey Medical School / University Hospital
RECRUITING
Newark
Contact Information
Primary
Garrett Gianneschi, Medical
garrettgianneschi@gmail.com
908-294-1161
Backup
Onajovwe Fofah, Medical
fofahon@njms.rutgers.edu
973-972-6753
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 24
Treatments
Experimental: Non-blinded, open label experimental arm
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.
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov