Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

NCT ID: NCT06797219

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2028-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Onajovwe Fofah, MD

Department of Pediatrics Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onajovwe Fofah, Medical

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Rutgers - New Jersey Medical School / University Hospital

Newark, New Jersey, United States

Site Status: RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Garrett Gianneschi, Medical

Role: CONTACT

garrettgianneschi@gmail.com

908-294-1161

Onajovwe Fofah, Medical

Role: CONTACT

fofahon@njms.rutgers.edu

973-972-6753

Facility Contacts

Garrett Gianneschi, DO

Role: primary

gbg30@rutgers.edu

9082941161

Garrett Gianneschi

Role: primary

gbg30@rutgers.edu

9082941161

References

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.

Reference Type: BACKGROUND

PMID: 37775549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19233936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21182447 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22299818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17463313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25695843 (View on PubMed)

Other Identifiers

Pro2023001886

Identifier Type: -

Identifier Source: org_study_id