RecruitingNot ApplicableNCT06797219

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4


Sponsor

Rutgers, The State University of New Jersey

Enrollment

24 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 DaysMax Age: 1 Month

Inclusion Criteria1

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

Exclusion Criteria1

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

Interventions

DEVICELow Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

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.


Locations(2)

Rutgers - New Jersey Medical School / University Hospital

Newark, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

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NCT06797219


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