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

ISRCTN ISRCTN18523491
DOI https://doi.org/10.1186/ISRCTN18523491
EudraCT/CTIS number 2010-018737-21
ClinicalTrials.gov number NCT01079715
Secondary identifying numbers EudraCT Number 2010-018737-21
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 Children’s Hospital
Viale Pieraccini 24
Florence
I-50139
Italy

Study information

Study designInterventional randomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleEvaluating 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 acronymPROP-ROP
Study objectivesTo 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) studiedRetinopathy of prematurity (ROP), the leading cause of blindness in children
InterventionParents 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 typeOther
Primary outcome measureTo 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 measuresTo 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 study start date01/01/2010
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants44 newborns
Key inclusion criteriaThe 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 criteria1. 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 enrolment01/01/2010
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Italy

Study participating centre

Neonatal Intensive Care Unit
Florence
I-50139
Italy

Sponsor information

A. Meyer University Children's Hospital (Italy)
Hospital/treatment centre

Viale Pieraccini 24
Florence
I-50139
Italy

Phone +39 (0)55 5662434
Email diraz@meyer.it
Website http://www.meyer.it
ROR logo "ROR" https://ror.org/01n2xwm51

Funders

Funder type

Hospital/treatment centre

A. Meyer University Children's Hospital (Italy)

No information available

Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena (Italy)

No information available

University of Milan (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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