Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

NCT06797219 | Recruiting FDA Device

• 1 other identifier: Pro2023001886
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Hemorrhage Resorption Rate

  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

  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

  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

  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

  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

  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

Study Arms (1)

Non-blinded, open label experimental arm

EXPERIMENTAL

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

Interventions

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.

Non-blinded, open label experimental arm

Eligibility Criteria

• Age: 0 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Rutgers - New Jersey Medical School / University Hospital

Newark, New Jersey, 07103, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Related Publications (6)

• Li D, Liu S, Yu T, Liu Z, Sun S, Bragin D, Shirokov A, Navolokin N, Bragina O, Hu Z, Kurths J, Fedosov I, Blokhina I, Dubrovski A, Khorovodov A, Terskov A, Tzoy M, Semyachkina-Glushkovskaya O, Zhu D. Photostimulation of brain lymphatics in male newborn and adult rodents for therapy of intraventricular hemorrhage. Nat Commun. 2023 Sep 29;14(1):6104. doi: 10.1038/s41467-023-41710-y.

  PMID: 37775549 BACKGROUND

• Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.

  PMID: 19233936 BACKGROUND

• Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23.

  PMID: 21182447 BACKGROUND

• Huisa BN, Stemer AB, Walker MG, Rapp K, Meyer BC, Zivin JA; NEST-1 and -2 investigators. Transcranial laser therapy for acute ischemic stroke: a pooled analysis of NEST-1 and NEST-2. Int J Stroke. 2013 Jul;8(5):315-20. doi: 10.1111/j.1747-4949.2011.00754.x. Epub 2012 Feb 2.

  PMID: 22299818 BACKGROUND

• Lampl Y, Zivin JA, Fisher M, Lew R, Welin L, Dahlof B, Borenstein P, Andersson B, Perez J, Caparo C, Ilic S, Oron U. Infrared laser therapy for ischemic stroke: a new treatment strategy: results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1). Stroke. 2007 Jun;38(6):1843-9. doi: 10.1161/STROKEAHA.106.478230. Epub 2007 Apr 26.

  PMID: 17463313 BACKGROUND

• Kent AL, Broom M, Parr V, Essex RW, Abdel-Latif ME, Dahlstrom JE, Valter K, Provis J, Natoli R. A safety and feasibility study of the use of 670 nm red light in premature neonates. J Perinatol. 2015 Jul;35(7):493-6. doi: 10.1038/jp.2015.5. Epub 2015 Feb 19.

  PMID: 25695843 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Onajovwe Fofah, Medical

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garrett Gianneschi, Medical

CONTACT

908-294-1161; garrettgianneschi@gmail.com

Onajovwe Fofah, Medical

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Pediatrics Chair

Model Details: A device to promote resorption and recovery from intraventricular hemorrhage

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: January 28, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)