Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
Information source: Azienda Ospedaliero, Universitaria Meyer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retinopathy of Prematurity
Intervention: Propranolol (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Azienda Ospedaliero, Universitaria Meyer Official(s) and/or principal investigator(s):
Luca Filippi, M.D., Principal Investigator, Affiliation: Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy
Overall contact:
Luca Filippi, M.D., Phone: ++ 39-(0)55-5662434, Email: l.filippi@meyer.it
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.
Clinical Details
Official title: Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: The primary aim is to evaluate the safety of propranolol administration
Secondary outcome: The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP
Detailed description:
Retinopathy of Prematurity (ROP) is still a major cause of blindness in children in
developed countries around the world, and an increasing cause of blindness in developing
countries. The ablation of the retina with photocoagulation by laser or cryotherapy reduces
the incidence of blindness by suppressing the neovascular phase of ROP. However, the visual
outcomes after treatment are often poor. The development of ROP depends largely from
vascular endothelial growth factor (VEGF). The reduction of VEGF expression in the
neovascular phase might prevent destructive neovascularization in ROP.
The purpose of this study is to evaluate whether the administration of propranolol is safe
and is able to reduce the incidence of blindness by suppressing the neovascular phase of ROP
compared to a control group receiving conventional laser therapy.
Eligibility
Minimum age: 22 Weeks.
Maximum age: 32 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Infants who have been screened for ROP (≤32 weeks gestation) who develop Stage 2 ROP
in zone II-III without plus.
2. Informed Consent from a parent
Exclusion Criteria:
1. Newborns with one or more of the following conditions at the enrollment in the study:
- Heart failure.
- Recurrent episodes of bradycardia (Heart rate less than 90 bpm).
- Atrio-ventricular block (second or third degree).
- Significant congenital heart anomaly, not including patent ductus arteriosus,
patent foramen ovale or small ventricular septal defect.
- Hypotension.
- Renal failure.
- Cerebral hemorrhage.
- Other diseases which contraindicate the use of beta-blockers
2. Newborns with ROP stages more advances than Stage 2 in zone II-III without plus.
3. Informed Consent from a parent refused. This will mean that an infant automatically
will receive standard laser therapy. No data will be used from an infant without
Informed Consent.
Locations and Contacts
Luca Filippi, M.D., Phone: ++ 39-(0)55-5662434, Email: l.filippi@meyer.it
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer, Florence I-50139, Italy; Recruiting
Luca Filippi, M.D., Phone: ++ 39-(0)55-5662434, Email: l.filippi@meyer.it
Luca Filippi, MD, Principal Investigator
La Torre Agostino, M.D., Sub-Investigator
Pina Fortunato, M.D., Sub-Investigator
Patrizio Fiorini, M.D., Sub-Investigator
Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan I-20122, Italy; Recruiting
Giacomo Cavallaro, M.D., Phone: ++39 (0)2 5503.2907, Email: giacomo.cavallaro@mangiagalli.it
Giacomo Cavallaro, MD, Principal Investigator
Gloria Cristofori, MD, Sub-Investigator
Valentina Benedetti, MD, Sub-Investigator
Additional Information
Drug information
Related publications: 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.
Starting date: January 2010
Last updated: January 7, 2011
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