drugset / Trial / NCT01079715
Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
Phase 2/3
Completed
52 enrolled
Meyer Children's Hospital IRCCS
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.
Timeline
- Start
- 2010-01
- Primary completion
- 2012-10
- Completion
- 2012-10
Publications
- Background Filippi L, Cavallaro G, Fiorini P, Daniotti M, Benedetti V, Cristofori G, Araimo G, Ramenghi L, La Torre A, Fortunato P, Pollazzi L, la Marca G, Malvagia S, Bagnoli P, Ristori C, Dal Monte M, Bilia AR, Isacchi B, Furlanetto S, Tinelli F, Cioni G, Donzelli G, Osnaghi S, Mosca F. Study protocol: safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491. BMC Pediatr. 2010 Nov 18;10:83. doi: 10.1186/1471-2431-10-83.
- Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr. 2013 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propranolol | Small molecule | 0.25 mg/kg | Oral |
| Subject | Propranolol | Small molecule | 0.5 mg/kg | Oral |