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NCT Number: NCT06797219

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

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.

Recruiting

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Key information

Age range

0 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newark Beth Israel Medical Center, Newark, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Device

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.

Primary outcomes

  1. 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

  2. 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.

  3. Neurosurgical Interventions

    Time frame: Number of neurosurgical interventions starts at birth and continues up to 4 months old

    number of patients requiring neurosurgical intervention

  4. 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)

  5. 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.

  6. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Garrett Gianneschi, Medical

CONTACT

[email protected]

908-294-1161

Onajovwe Fofah, Medical

CONTACT

[email protected]

973-972-6753

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: EFIL

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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