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

Primary Purpose

Retinopathy of Prematurity

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Azienda Ospedaliero, Universitaria Meyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Newborn, Retinal Diseases, Angiogenesis Modulating Agents, Adrenergic beta-Antagonists

Eligibility Criteria

22 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Infants who have been screened for ROP (≤ 32 weeks gestation) who develop Stage 2 ROP in zone II without plus.
  2. Informed Consent from a parent

Exclusion Criteria:

  1. Newborns with one or more of the following conditions at the enrollment in the study:

    • Heart failure.
    • Recurrent episodes of bradycardia (Heart rate less than 90 bpm).
    • Atrio-ventricular block (second or third degree).
    • Significant congenital heart anomaly, not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect.
    • Hypotension.
    • Renal failure.
    • Cerebral hemorrhage.
    • Other diseases which contraindicate the use of beta-blockers
  2. Newborns with ROP stages more advances than Stage 2 in zone II 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.

Sites / Locations

  • Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer
  • Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Propranolol

Control

Arm Description

Oral Propranolol administration is the experimental arm of this study

Control arm is treated following the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group

Outcomes

Primary Outcome Measures

The primary aim is to evaluate the safety of propranolol administration

Secondary Outcome Measures

The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP

Full Information

First Posted
March 2, 2010
Last Updated
November 24, 2012
Sponsor
Azienda Ospedaliero, Universitaria Meyer
Collaborators
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
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1. Study Identification

Unique Protocol Identification Number
NCT01079715
Brief Title
Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
Acronym
PROP-ROP
Official Title
Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Meyer
Collaborators
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.
Detailed Description
Retinopathy of Prematurity (ROP) is still a major cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The ablation of the retina with photocoagulation by laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP. However, the visual outcomes after treatment are often poor. The development of ROP depends largely from vascular endothelial growth factor (VEGF). The reduction of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The purpose of this study is to evaluate whether the administration of propranolol is safe and is able to reduce the incidence of blindness by suppressing the neovascular phase of ROP compared to a control group receiving conventional laser therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
Newborn, Retinal Diseases, Angiogenesis Modulating Agents, Adrenergic beta-Antagonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Oral Propranolol administration is the experimental arm of this study
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control arm is treated following the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
Dosage of 0.5mg/Kg oral, every 6 hours. The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm). In case such events occur in any of the 3 groups of gestational age, the study could start again with half dose (0.25mg/Kg oral, every 6 hours) after notification to the Ethics Committee. In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery. In cases of severe hypotension or bradycardia may be administered one or more of the following drugs: Atropine. Isoproterenol hydrochloride (isoprenaline. Terlipressin. Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).
Primary Outcome Measure Information:
Title
The primary aim is to evaluate the safety of propranolol administration
Time Frame
Three months
Secondary Outcome Measure Information:
Title
The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP
Time Frame
six months from the beginning of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants who have been screened for ROP (≤ 32 weeks gestation) who develop Stage 2 ROP in zone II without plus. Informed Consent from a parent Exclusion Criteria: Newborns with one or more of the following conditions at the enrollment in the study: Heart failure. Recurrent episodes of bradycardia (Heart rate less than 90 bpm). Atrio-ventricular block (second or third degree). Significant congenital heart anomaly, not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect. Hypotension. Renal failure. Cerebral hemorrhage. Other diseases which contraindicate the use of beta-blockers Newborns with ROP stages more advances than Stage 2 in zone II without plus. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Filippi, M.D.
Organizational Affiliation
Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer
City
Florence
ZIP/Postal Code
I-50139
Country
Italy
Facility Name
Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
I-20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21087499
Citation
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 Nov 18;10:83. doi: 10.1186/1471-2431-10-83.
Results Reference
background
PubMed Identifier
24054431
Citation
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 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/
Description
Drug information

Learn more about this trial

Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

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