NCT06797219 Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
| NCT ID | NCT06797219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Intraventricular Hemorrhage of Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-02-25 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Onajovwe Fofah, Medical
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey
Frequently Asked Questions
Who can join the NCT06797219 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 1 Month, studying Intraventricular Hemorrhage of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797219 currently recruiting?
Yes, NCT06797219 is actively recruiting participants. Contact the research team at garrettgianneschi@gmail.com for enrollment information.
Where is the NCT06797219 trial being conducted?
This trial is being conducted at Newark, United States, Newark, United States.
Who is sponsoring the NCT06797219 clinical trial?
NCT06797219 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Onajovwe Fofah, Medical at Rutgers, The State University of New Jersey. The trial plans to enroll 24 participants.