Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Not Applicable

Recruiting

• Conditions: Intraventricular Hemorrhage of Prematurity; Hydrocephalus

• Registration Number: NCT06797219
• Lead Sponsor: Rutgers, The State University of New Jersey

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\' 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-06
• Study Start: 2024-11-25
• Status Verified: 2024-12
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-07-01
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hemorrhage Resorption Rate	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 rate at which neonate intraventricular hemorrhage is resorbed via serial head ultrasounds
Neurosurgical Interventions	Number of neurosurgical interventions starts at birth and continues up to 4 months old	number of patients requiring neurosurgical intervention
Anterior Horn Width	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 rate at which neonate intracranial pressure changes using anterior horn width (mm) derived from serial head ultrasounds.
Neurodevelopmental Outcomes at 6 months and 12 months of age	Two time points at 6 months of age 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)
Ventricular Index	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 rate at which neonate intracranial pressure changes using ventricular index (mm) derived from serial head ultrasounds.
Head Circumference	Head Circumference tracking starts from birth and is performed daily up to 4 months old	Measure rate at which neonate intracranial pressure changes via head circumference (cm).

Trial Locations

Locations (2)

Rutgers - New Jersey Medical School / University Hospital; 🇺🇸 Newark, New Jersey, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States