Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)
ISRCTN | ISRCTN18523491 |
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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
Scientific
Neonatal Intensive Care Unit
Department of Critical Care Medicine
A. Meyer University Childrens Hospital
Viale Pieraccini 24
Florence
I-50139
Italy
Study information
Study design | Interventional randomised active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/01/2010 |
Completion date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 44 newborns |
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
I-50139
Italy
Sponsor information
A. Meyer University Children's Hospital (Italy)
Hospital/treatment centre
Hospital/treatment centre
Viale Pieraccini 24
Florence
I-50139
Italy
Phone | +39 (0)55 5662434 |
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diraz@meyer.it | |
Website | http://www.meyer.it |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 18/11/2010 | Yes | No | |
Results article | results | 01/12/2013 | Yes | No |