Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity

NCT01079715 | Completed Phase 2 DMC

• 1 other identifier: EudraCT Number 2010-018737-21
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinopathy of Prematurity

Keywords

Newborn; Retinal Diseases; Angiogenesis Modulating Agents; Adrenergic beta-Antagonists

Outcome Measures

Primary Outcomes (1)

• The primary aim is to evaluate the safety of propranolol administration

  Three months

Secondary Outcomes (1)

• 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

Study Arms (2)

Propranolol

EXPERIMENTAL

Oral Propranolol administration is the experimental arm of this study

Drug: Propranolol

Control

NO INTERVENTION

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

Interventions

Propranolol DRUG

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).

Propranolol

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead
• Ospedale Maggiore Policlinico Mangiagalli e Regina Elena: collaborator

Study Sites (2)

Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer

Florence, I-50139, Italy

Location

Neonatal Intensive Care Unit - Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

Milan, I-20122, Italy

Location

Related Publications (2)

• 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.

  PMID: 21087499 BACKGROUND

• 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.

  PMID: 24054431 DERIVED

Related Links

• Drug information

MeSH Terms

Conditions

Retinopathy of Prematurity; Retinal Diseases

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Luca Filippi, M.D.

  Azienda Ospedaliero-Universitaria A. Meyer, Firenze, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Luca Filippi

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

IT (2)