Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity (PROP-ROP)
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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 |
- The primary aim is to evaluate the safety of propranolol administration [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
- 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:
|
|
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 |
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.
Contacts and 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 | |
| Principal Investigator: | Luca Filippi, M.D. | Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy |
More Information
Additional Information:
Publications:
| 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 Adrenergic beta-Antagonists Propranolol Angiogenesis Modulating Agents 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 May 21, 2013