Additional identifiers
EudraCT number
2010-018737-21
ClinicalTrials.gov number
NCT01079715
Protocol/serial number
EudraCT Number 2010-018737-21
Study information
Scientific title
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
Acronym
PROP-ROP
Study hypothesis
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.
Ethics approval
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).
Study design
Interventional randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Retinopathy of prematurity (ROP), the leading cause of blindness in children
Intervention
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.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
44 newborns
Participant 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.
Recruitment start date
01/01/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Italy
Trial participating centre
Neonatal Intensive Care Unit
Florence
I-50139
Italy
Sponsor information
Organisation
A. Meyer University Children's Hospital (Italy)
Sponsor details
Viale Pieraccini 24
Florence
I-50139
Italy
+39 (0)55 5662434
diraz@meyer.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
A. Meyer University Children's Hospital (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Milan (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21087499
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24054431
Publication citations
-
Protocol
Filippi L, Cavallaro G, Fiorini P, Daniotti M, Benedetti V, Cristofori G, Araimo G, Ramenghi L, La Torre A, Fortunato P, Pollazzi L, la Marca G, Malvagia S, Bagnoli P, Ristori C, Dal Monte M, Bilia AR, Isacchi B, Furlanetto S, Tinelli F, Cioni G, Donzelli G, Osnaghi S, Mosca F, Study protocol: safety and efficacy of propranolol in newborns with Retinopathy of Prematurity (PROP-ROP): ISRCTN18523491., BMC Pediatr, 2010, 10, 83, doi: 10.1186/1471-2431-10-83.
-
Results
Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F, Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives., J. Pediatr., 2013, 163, 6, 1570-1577.e6, doi: 10.1016/j.jpeds.2013.07.049.