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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

Page last updated: December 08, 2011

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