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ISRCTN
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ISRCTN18523491
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ClinicalTrials.gov identifier
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NCT01079715
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Public title
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Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)
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Scientific title
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Evaluating the safety and efficacy of propranolol administration in preterm newborns suffering from a precocious phase of retinopathy of prematurity (ROP): A randomised controlled trial
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Acronym
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PROP-ROP
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Serial number at source
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EudraCT Number 2010-018737-21
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Study hypothesis
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To evaluate the safety of propranolol administration in preterm newborns suffering from a precocious phase of retinopathy of prematurity (ROP) and its efficacy to reduce the disease progression, the incidence retinal detachment and of blindness, by suppressing the neovascular phase of ROP compared to a control group receiving conventional treatment.
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Lay summary
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Ethics approval
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The Centre Research Ethics Board (Comitato Etico Sperimentazione dei Medicinali [CESM]) of A. Meyer University Children's Hospital, Florence and of the Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan approved on the 14th of January 2010 (ref: 277/2010).
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Study design
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Interventional randomised active controlled parallel group trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Retinopathy of prematurity (ROP), the leading cause of blindness in children
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/01/2010
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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44 newborns
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Interventions
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Parents of newborns who meet the inclusion criteria will be approached by the study investigator/nurse, informed of the study. Signed written informed consent will be obtained.
Patients will be randomised to receive:
1. Intervention: Administration of propranolol. Dosage of 0.5mg/Kg orally, every 6 hours in the treated arm. This treatment will be continued until vascularization of retina will be complete.
2. Control: Treatment as usual. Standard laser therapy.
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Primary outcome measure(s)
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To evaluate the safety of propranolol administration in preterm newborns suffering from a precocious phase of ROP.
In order to evaluate the safety of this treatment, heart frequency, blood pressure, oxygen saturation, respiratory support, will be continuously monitored.
Blood samplings to check renal, liver and metabolic balance will be performed weekly for the first 4 weeks of treatment.
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Secondary outcome measure(s)
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To evaluate the safety of propranolol administration in preterm newborns suffering from a precocious phase of ROP.
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.
The follow-up planned at 1, 4 and half, 6, 12, 18 and 24 months, will allow to evaluate the functional outcome.
Visual acuity will be evaluate at 1, 4 and half, and 12 months of corrected age.
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Sources of funding
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1. A. Meyer University Children's Hospital (Italy)
2. Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena (Italy)
3. University of Milan (Italy)
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Trial website
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Publications
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1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21087499
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Contact name
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Dr
Luca
Filippi
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Address
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Neonatal Intensive Care Unit
Department of Critical Care Medicine
A. Meyer University Children’s Hospital
Viale Pieraccini 24
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City/town
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Florence
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Zip/Postcode
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I-50139
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Country
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Italy
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Sponsor
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A. Meyer University Children's Hospital (Italy)
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Address
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Viale Pieraccini 24
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City/town
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Florence
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Zip/Postcode
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I-50139
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Country
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Italy
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Tel
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+39 (0)55 5662434
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Fax
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+39 (0)55 5662400
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Email
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diraz@meyer.it
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Sponsor website:
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http://www.meyer.it
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Date applied
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06/06/2010
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Last edited
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02/03/2011
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Date ISRCTN assigned
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12/07/2010
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