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โ† Trials
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Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

RecruitingNAAges 0 Days - 1 MonthAllRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
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Where

2 sites
Rutgers - New Jersey Medical School / University Hospital
Newark, United States
Newark Beth Israel Medical Center
Newark, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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