Intraventricular Hemorrhage of PrematurityEFILNCT06797219
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
A study testing Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity in people with Intraventricular Hemorrhage of Prematurity and Hydrocephalus, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 1 month
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity, Hydrocephalus
- What is being tested?
- Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
Who cannot join
- neonates without IVH grade 3/4 or older than 1 month.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, 07103
Garrett Gianneschi, DO, 9082941161, gbg30@rutgers.edu
Bellipady Rai, MD
- Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Garrett Gianneschi, 9082941161, gbg30@rutgers.edu
Onajovwe Fofah, MD
About this study
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.
- Being tested
- Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
- Keywords
- low level laser therapy, neonate, developmental milestones, intraventricular hemorrhage
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser Therapy for Intraventricular Hemorrhage of PrematurityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhage Resorption Rate
Measure rate at which neonate intraventricular hemorrhage is resorbed via serial head ultrasounds
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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).
Measured: Head Circumference tracking starts from birth and is performed daily up to 4 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Feb 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A device to promote resorption and recovery from intraventricular hemorrhage
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onajovwe Fofah, MD, Rutgers, The State University of New Jersey
- Investigators
- Onajovwe Fofah, Medical, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797219
- Sponsor's protocol ID
- Pro2023001886
- Acronym
- EFIL
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37775549Zivin 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.
PubMed 19233936Naeser 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.
PubMed 21182447Huisa 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.
PubMed 22299818Lampl 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.
PubMed 17463313Kent 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.
PubMed 25695843
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
- ClinicalTrials.gov ID
- NCT06797219
- Acronym / sponsor ID
- EFIL / Pro2023001886
- Keywords
- low level laser therapy, neonate, developmental milestones, intraventricular hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A device to promote resorption and recovery from intraventricular hemorrhage
| Arm | Type | Receives |
|---|---|---|
| Non-blinded, open label experimental arm | Experimental | Device: Low Level Laser Therapy for Intraventricular Hemorrhage of PrematurityThe 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. |
Who may qualify
- Ages
- 0 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
Key exclusion criteria (1 listed)
- neonates without IVH grade 3/4 or older than 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser Therapy for Intraventricular Hemorrhage of PrematurityThe 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 | Non-blinded, open label experimental arm |
Primary outcome
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
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.
Neurosurgical Interventions
Time frame: Number of neurosurgical interventions starts at birth and continues up to 4 months old
number of patients requiring neurosurgical intervention
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)
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 37775549Li 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.
- Background: PubMed 19233936Zivin 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.
- Background: PubMed 21182447Naeser 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.
- Background: PubMed 22299818Huisa 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.
- Background: PubMed 17463313Lampl 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.
- Background: PubMed 25695843Kent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onajovwe Fofah, Medical principal investigator
Rutgers, The State University of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity in people with Intraventricular Hemorrhage of Prematurity and Hydrocephalus, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Garrett Gianneschi, Medical (908-294-1161, garrettgianneschi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06797219, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.