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

This study has been completed.
Sponsor:
Collaborator:
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Information provided by (Responsible Party):
Luca Filippi, Azienda Ospedaliero, Universitaria Meyer
ClinicalTrials.gov Identifier:
NCT01079715
First received: March 2, 2010
Last updated: November 24, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine whether the administration of propranolol is effective in the treatment of the retinopathy of the prematurity.


Condition Intervention Phase
Retinopathy of Prematurity
Drug: Propranolol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Meyer:

Primary Outcome Measures:
  • The primary aim is to evaluate the safety of propranolol administration [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

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 [ Time Frame: six months from the beginning of treatment ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propranolol
Oral Propranolol administration is the experimental arm of this study
Drug: Propranolol

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).
No Intervention: Control
Control arm is treated following the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group

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.

  Eligibility

Ages Eligible for Study:   22 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079715

Locations
Italy
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer
Florence, Italy, I-50139
Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
Milan, Italy, I-20122
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Meyer
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Investigators
Principal Investigator: Luca Filippi, M.D. Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luca Filippi, Dr. Luca Filippi, Azienda Ospedaliero, Universitaria Meyer
ClinicalTrials.gov Identifier: NCT01079715     History of Changes
Other Study ID Numbers: EudraCT Number 2010-018737-21
Study First Received: March 2, 2010
Last Updated: November 24, 2012
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda Ospedaliero, Universitaria Meyer:
Newborn
Retinal Diseases
Angiogenesis Modulating Agents
Adrenergic beta-Antagonists

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Propranolol
Angiogenesis Modulating Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Growth Substances

ClinicalTrials.gov processed this record on September 16, 2014