Hydrocephalus, Intraventricular Hemorrhage of Prematurity
Conditions
Keywords
low level laser therapy, neonate, developmental milestones, intraventricular hemorrhage
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.
Interventions
DEVICELow Level Laser Therapy for Intraventricular Hemorrhage of Prematurity
The 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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A device to promote resorption and recovery from intraventricular hemorrhage
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Neurosurgical Interventions | Number of neurosurgical interventions starts at birth and continues up to 4 months old | number of patients requiring neurosurgical intervention |
| 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). |
Countries
United States
Contacts
Primary ContactGarrett Gianneschi, Medical
Backup ContactOnajovwe Fofah, Medical
Outcome results
None listed