Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4 (EFIL)

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Hydrocephalus; Intraventricular Hemorrhage of Prematurity

Treatments: Device: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Study type: Interventional

Funder types: Other

Identifiers

NCT06797219

Pro2023001886

Details and patient eligibility

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.

Enrollment: 24 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Non-blinded, open label experimental arm

Experimental group

Description:

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.

Treatment:

Device: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity