Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)

Completed

• Conditions: Retinopathy of prematurity (ROP), the leading cause of blindness in children; Neonatal Diseases; Other retinal disorders

• Registration Number: ISRCTN18523491
• Lead Sponsor: A. Meyer University Children's Hospital (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

The studied population consists of preterm infants delivered at less than 32 weeks gestational age admitted to the Neonatal Intensive Care Unit at the A. Meyer University Children's Hospital, Florence and at the Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan.
1. Infants who have been screened for ROP (=32 weeks gestation) who developed zone II-III, stage 2 ROP without plus.
2. Informed Consent from a parent

Exclusion Criteria

1. Newborns with congenital cardiovascular anomalies, renal failure, cerebral haemorrhage, which contraindicate the use of beta-blockers
2. Newborns with ROP stages more advances than zone II-III, stage 2 ROP 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of propranolol administration in preterm newborns suffering from a precocious phase of ROP. <br>In order to evaluate the safety of this treatment, heart frequency, blood pressure, oxygen saturation, respiratory support, will be continuously monitored. <br>Blood samplings to check renal, liver and metabolic balance will be performed weekly for the first 4 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of propranolol administration in preterm newborns suffering from a precocious phase of ROP. <br>In order to evaluate the efficacy of this treatment, serial ophthalmologic evaluations will be planned at different intervals according to the severity of ROP. The efficacy will be evaluated comparing the different incidence of the progression of ROP to stages 3 or to retinal detachment, the different incidence of laser treatment, the different incidence of vitrectomy, between the two groups. <br>The follow-up planned at 1, 4 and half, 6, 12, 18 and 24 months, will allow to evaluate the functional outcome. <br>Visual acuity will be evaluate at 1, 4 and half, and 12 months of corrected age.