Clinical trial NCT06797219: Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Official title: Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage of Prematurity
Hydrocephalus
Keywords: low level laser therapy
neonate
developmental milestones
intraventricular hemorrhage
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A device to promote resorption and recovery from intraventricular hemorrhage
Primary purpose: TREATMENT

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\&#39; 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: 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.

Primary outcomes:
measure: Hemorrhage Resorption Rate
timeFrame: 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: Anterior Horn Width
timeFrame: 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: Neurosurgical Interventions
timeFrame: Number of neurosurgical interventions starts at birth and continues up to 4 months old
measure: Neurodevelopmental Outcomes at 6 months and 12 months of age
timeFrame: Two time points at 6 months of age and 12 months of age
measure: Ventricular Index
timeFrame: 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: Head Circumference
timeFrame: Head Circumference tracking starts from birth and is performed daily up to 4 months old
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School / University Hospital
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Onajovwe Fofah, Medical
role: PRINCIPAL_INVESTIGATOR
References:
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