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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
DeviceThe 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Non-blinded, open label experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 old2
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 old3
Neurosurgical Interventions
number of patients requiring neurosurgical intervention
Time frame
Number of neurosurgical interventions starts at birth and continues up to 4 months old4
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 ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov