Recruiting

Light Therapy

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06797219

Conditions

Intraventricular Hemorrhage of Prematurity

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Study Details

Brief 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.

Conditions

Intraventricular Hemorrhage of Prematurity

Hydrocephalus

Study ID

NCT06797219

Start date

Feb 25, 2025

Status verified date

Jul, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]
  • Neurosurgical Interventions [ Time Frame: 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 ]
  • 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 ]
  • Head Circumference [ Time Frame: Head Circumference tracking starts from birth and is performed daily up to 4 months old ]

Central Contacts and Locations

Central contacts

Garrett Gianneschi, Medical

908-294-1161garrettgianneschi@gmail.com

Onajovwe Fofah, Medical

973-972-6753fofahon@njms.rutgers.edu

Locations

Rutgers - New Jersey Medical School / University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Garrett Gianneschi, DO

9082941161gbg30@rutgers.edu

Principal Investigator:

Bellipady Rai, MD

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Garrett Gianneschi

9082941161gbg30@rutgers.edu

Principal Investigator:

Onajovwe Fofah, MD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 22, 2025

Last verified

Jul, 2025

Keywords

  • low level laser therapy
  • neonate
  • developmental milestones
  • intraventricular hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-07-22.