The medical condition to be investigated is Retinopathy of Prematurity (ROP)
Conditions
Interventions
Product Name: propranolol
Product Code: C07AA05
Pharmaceutical Form: Eye drops
INN or Proposed INN: PROPRANOLOL HYDROCHLORIDE
CAS Number: 318-98-9
Concentration unit: µl microlitre(s)
Concentration ty
Sponsors
Azienda Ospedaliero-Universitaria Meyer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preterm newborns (gestational age lower than 32 weeks) who develop stage 2 ROP (zone II without plus). Are the trial subjects under 18? yes Number of subjects for this age range: 55 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Newborns with heart failure, bradycardia, atrioventricular blocks, congenital cardiovascular anomalies, hypotension, renal failure, failure to thrive, cerebral haemorrhage, other diseases that contraindicate the use of beta-blockers. 2. Newborns with ROP at a more advanced stage than stage 2 (zone II without plus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Main Objective: To reduce the progression of Retinopathy of Prematurity;Primary end point(s): 1. To evaluate the efficacy of propranolol to reduce the progression of ROP to stage 2 or 3 with plus. 2. To evaluate the plasma levels of propranolol in newborns enrolled ;Timepoint(s) of evaluation of this end point: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To evaluate the efficacy of propranolol to reduce the progression of ROP to stage 4 or 5. 2. To evaluate the number of newborns treated with laser ;Timepoint(s) of evaluation of this end point: 60 days | — |
Countries
Italy
Contacts
Public ContactComitato Etico
Azienda Ospedaliero-Universitaria Meyer
Outcome results
None listed