Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

— PROP-ROP  

Official title:

Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079715
• Other study ID #: EudraCT Number 2010-018737-21
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 2, 2010
• Last updated: November 24, 2012
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Azienda Ospedaliero, Universitaria Meyer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Weeks to 32 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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).

Locations

Country	Name	City	State
Italy	Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer	Florence
Italy	Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Meyer	Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim is to evaluate the safety of propranolol administration		Three months	Yes
Secondary	The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP		six months from the beginning of treatment	No

External Links

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