Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
A legfontosabb adatok
- Hol
- Newark (Egyesült Államok)Mind a 2 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Newark Beth Israel Medical CenterNewark, Egyesült ÁllamokContact: Garrett GianneschiRésztvevőt keres
- Rutgers New Jersey Medical School/University HospitalNewark, Egyesült ÁllamokContact: Garrett Gianneschi, DORésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Rutgers, The State University of New Jersey
- Azonosító
- NCT06797219
- A regiszteradat frissítve
- 2025. július 22.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
Kizáró feltételek: neonates without IVH grade 3/4 or older than 1 month.