Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
Recruiting
N/A
Interventional Study
Intraventricular Hemorrhage of Prematurity
Hydrocephalus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Days – 1 Month
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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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 …
Trial Locations
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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.
Contacts