An interventional study of Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity in Intraventricular Hemorrhage of Prematurity and Hydrocephalus, sponsored by Rutgers, The State University of New Jersey. Recruiting at 2 sites in United States. Open to participants aged 0 Days to 1 Month. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment
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.
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 105 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Hemorrhage Resorption Rate
Measure rate at which neonate intraventricular hemorrhage is resorbed via serial head ultrasounds
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
Anterior Horn Width
Measure rate at which neonate intracranial pressure changes using anterior horn width (mm) derived from serial head ultrasounds.
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
Neurosurgical Interventions
number of patients requiring neurosurgical intervention
Time frame: 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)
Time frame: 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.
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
Head Circumference
Measure rate at which neonate intracranial pressure changes via head circumference (cm).
Time frame: Head Circumference tracking starts from birth and is performed daily up to 4 months old
Plan to share: No
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Rutgers, The State University of New Jersey