Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Hemorrhage Resorption Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to 1 Month (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity (Device)
Outcomes
Primary Outcomes
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
Neurosurgical Interventions
Time Frame: Number of neurosurgical interventions starts at birth and continues up to 4 months old
number of patients requiring neurosurgical intervention
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.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Onajovwe Fofah, MD
Department of Pediatrics Chair
Rutgers, The State University of New Jersey