Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Last updated: January 22, 2025
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Stroke

Hemorrhage

Treatment

Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Clinical Study ID

NCT06797219
Pro2023001886
  • Ages < 1
  • All Genders

Study 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&#39; 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • neonates without IVH grade 3/4 or older than 1 month.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
Phase:
Study Start date:
November 25, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Active - Recruiting

  • Rutgers - New Jersey Medical School / University Hospital

    Newark, New Jersey 07103
    United States

    Active - Recruiting

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