Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

Qualifiers

neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.

Disqualifiers

neonates without IVH grade 3/4 or older than 1 month.

Trial design

Treatments tested in this trial

  • Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity

Treatment groups

24 Participants
are divided into 1 treatment group