Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero, Universitaria Meyer
• Collaborator: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
• Treatments: Angiogenesis Modulating Agents; Propranolol

Criteria

Inclusion Criteria:

1. Infants who have been screened for ROP (≤ 32 weeks gestation) who develop Stage 2 ROP in zone II 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 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.