Clinical trial NCT01079715: Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
Official title: Safety and Efficacy of Treatment With Propranolol in Newborns With Retinopathy of Prematurity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Retinopathy of Prematurity
Keywords: Newborn
Retinal Diseases
Angiogenesis Modulating Agents
Adrenergic beta-Antagonists
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
First posted: 2010-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The primary aim is to evaluate the safety of propranolol administration
timeFrame: Three months
Secondary outcomes:
measure: The secondary aim is to evaluate the efficacy of treatment with propranolol for reducing blindness and retinal detachment in newborns with ROP
timeFrame: six months from the beginning of treatment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer
city: Milan
country: Italy
facility: Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
Study officials:
affiliation: Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy
name: Luca Filippi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.