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

July 16, 2025 updated by: Onajovwe Fofah, MD, Rutgers, The State University of New Jersey
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • Onajovwe Fofah, MD
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers - New Jersey Medical School / University Hospital
        • Contact:
        • Principal Investigator:
          • Bellipady Rai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Low 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhage Resorption Rate
Time Frame: Hemorrhage resorption rate tracking starts from date of identified intraventricular hemorrhage on head ultrasound (usually within 1 week of life) and head ultrasounds weekly up to 4 months old
Measure rate at which neonate intraventricular hemorrhage is resorbed via serial head ultrasounds
Hemorrhage resorption rate tracking starts from date of identified intraventricular hemorrhage on head ultrasound (usually within 1 week of life) and head ultrasounds weekly up to 4 months old
Anterior Horn Width
Time Frame: Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life) performed through weekly head ultrasounds up to 4 months old
Measure rate at which neonate intracranial pressure changes using anterior horn width (mm) derived from serial head ultrasounds.
Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life) performed through weekly head ultrasounds up to 4 months old
Neurosurgical Interventions
Time Frame: Number of neurosurgical interventions starts at birth and continues up to 4 months old
number of patients requiring neurosurgical intervention
Number of neurosurgical interventions starts at birth and continues up to 4 months old
Neurodevelopmental Outcomes at 6 months and 12 months of age
Time Frame: Two time points at 6 months of age and 12 months of age
A phone survey will be conducted inquiring which developmental milestones have been met at 6 months (i.e., sitting independently, reaching to grab toys, knows familiar people, takes turns making sounds with care giver) and 12 months (plays interactive games, says mama/dada, looks for hidden objects, cruises, pincer grasp)
Two time points at 6 months of age and 12 months of age
Ventricular Index
Time Frame: Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life); and subsequent weekly head ultrasounds performed up to 4 months old
Measure rate at which neonate intracranial pressure changes using ventricular index (mm) derived from serial head ultrasounds.
Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life); and subsequent weekly head ultrasounds performed up to 4 months old
Head Circumference
Time Frame: Head Circumference tracking starts from birth and is performed daily up to 4 months old
Measure rate at which neonate intracranial pressure changes via head circumference (cm).
Head Circumference tracking starts from birth and is performed daily up to 4 months old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Onajovwe Fofah, Medical, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2023001886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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