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

ISRCTN	ISRCTN18523491
DOI	https://doi.org/10.1186/ISRCTN18523491
ClinicalTrials.gov (NCT)	NCT01079715
Clinical Trials Information System (CTIS)	2010-018737-21
Protocol serial number	EudraCT Number 2010-018737-21
Sponsor	A. Meyer University Children's Hospital (Italy)
Funders	A. Meyer University Children's Hospital (Italy), Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena (Italy), University of Milan (Italy)

Submission date: 06/06/2010
Registration date: 12/07/2010
Last edited: 29/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luca Filippi
Scientific

Neonatal Intensive Care Unit
Department of Critical Care Medicine
A. Meyer University Childrens Hospital
Viale Pieraccini 24
Florence
I-50139
Italy

Study information

Primary study design	Interventional
Study design	Interventional randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PROP-ROP
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	44
Key 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
Key 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.
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Italy

Study participating centre

Neonatal Intensive Care Unit

Florence
I-50139
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No
Protocol article	protocol	18/11/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes