Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

Meyer Children's Hospital IRCCS52 enrolled

Overview

The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Retinopathy of Prematurity

Interventions

PropranololDRUG

Dosage of 0.5mg/Kg oral, every 6 hours. The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm). In case such events occur in any of the 3 groups of gestational age, the study could start again with half dose (0.25mg/Kg oral, every 6 hours) after notification to the Ethics Committee. In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery. In cases of severe hypotension or bradycardia may be administered one or more of the following drugs: * Atropine. * Isoproterenol hydrochloride (isoprenaline. * Terlipressin. * Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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.

Locations (2)

Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer

Florence, Italy

Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

Milan, Italy

Outcomes

Primary Outcomes

The primary aim is to evaluate the safety of propranolol administration

Time frame: Three months

Secondary Outcomes

The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP

Time frame: six months from the beginning of treatment

Data from ClinicalTrials.gov

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