Condition category
Neonatal Diseases
Date applied
06/06/2010
Date assigned
12/07/2010
Last edited
29/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luca Filippi

ORCID ID

Contact details

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

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 measures

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

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

http://www.meyer.it

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes