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NCT06797219 · ClinicalTrials.gov registry record · NA
Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
A NA study of Hydrocephalus and Intraventricular Hemorrhage of Prematurity, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT06797219 is a NA study of Hydrocephalus and Intraventricular Hemorrhage of Prematurity that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 24 participants, below the 132-participant average among 17 other Hydrocephalus trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06797219, a NA study of Hydrocephalus and Intraventricular Hemorrhage of Prematurity, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DEVICE Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
Study Locations (2)
New Jersey
- Rutgers - New Jersey Medical School / University Hospital - Newark
- Newark Beth Israel Medical Center - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2028-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06797219
The ClinicalTrials.gov registry entry for NCT06797219 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 17 other Hydrocephalus trials with a reported enrollment target (82% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hydrocephalus appearing as the primary indexed condition, and to 1 intervention - of which Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity is the first listed.
NCT06797219 reports 2 study locations spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT06797219 about?
NCT06797219 is a clinical study titled "Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4". 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 pare...
What is the current status of trial NCT06797219?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2025-02-25. Estimated completion is 2028-07-31.
What conditions does trial NCT06797219 study?
This clinical trial studies the following conditions: Hydrocephalus, Intraventricular Hemorrhage of Prematurity.
What interventions are being tested in trial NCT06797219?
The interventions under investigation include: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity (DEVICE).
Who is sponsoring clinical trial NCT06797219?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06797219 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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