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Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Recruiting
1 years and younger
All
Phase N/A
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Overview

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

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.

Study details
    Intraventricular Hemorrhage of Prematurity
    Hydrocephalus

NCT06797219

Rutgers, The State University of New Jersey

15 October 2025

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