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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, United States
RECRUITINGNewark Beth Israel Medical Center
Newark, New Jersey, United States
RECRUITINGHemorrhage 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
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