Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study

This study has been completed.
Sponsor:
Collaborators:
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01238471
First received: November 8, 2010
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

In premature infants, propranolol (Prop) treatment might suppress continuing neo-vascularization (NV) and decelerate the progression of retinopathy of prematurity (ROP) towards its severe stages (III-V), thus avoiding the need of interventions (CRYO and/or LASER photo-coagulation of the ischemic retina and preventing severe ocular sequelae. We therefore plan to prospectively investigate the influence of prop versus placebo in VLBW infants with ROP stage 1 (zone I), with stage 2 or higher (any zone) or with Plus disease, along with close follow up regarding safety of prop administration and its effect on ROP.


Condition Intervention Phase
Retinopathy of Prematurity
Drug: propranolol
Drug: sucrose 5%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity (ROP): A Pilot, Randomized and Prospective Study.

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy [ Time Frame: propranolol therapy for up 4 weeks ] [ Designated as safety issue: Yes ]

    If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.

    Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina.



Secondary Outcome Measures:
  • Safety of Propranolol Therapy in Premature Infants [ Time Frame: 4 weeks of propranolol therapy in premature infants ] [ Designated as safety issue: Yes ]
    Close monitoring for possible side effects of propranolol in premature infants


Enrollment: 20
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propranolol
Oral propranolol for premature infants allocated to this arm by randomization
Drug: propranolol
2 mg per kg per day divided in 3 doses for 2-4 weeks
Other Names:
  • beta blocker
  • deralin
Placebo Comparator: Oral sucrose 5%
Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization
Drug: sucrose 5%
2 ml per Kg per day divided in 3 doses for 2-4 weeks
Other Name: sucrose sugar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Evidence for ROP that might progress and that includes any one of the following:

  • Stage 1 (zone I)
  • Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is according to International Classification of Retinopathy of Prematurity (ICROP) 2005 (40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is not included since it will always regress spontaneously.

Exclusion Criteria:

  • The presence of one or more of the following conditions at enrollment in the study:
  • More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [
  • Atrio-ventricular (A-V) block [2nd or 3rd degree]
  • Significant congenital heart anomaly [not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect]
  • Heart failure
  • Hypotension (mean blood pressure <45 mmHg)
  • Hypoglycemia (<50mg/dL)
  • Platelet count <100000/mm3
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01238471

Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Hadassah Medical Organization
Jerusalem, Israel
Nazareth Hospital
Nazareth, Israel
Laniado Hospital
Netanya, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01238471     History of Changes
Other Study ID Numbers: 0479-09CTIL, Israeli Health Ministry
Study First Received: November 8, 2010
Results First Received: May 12, 2014
Last Updated: June 12, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
retinopathy of prematurity
Propranolol
Vascular endothelial growth factor
premature infant

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

ClinicalTrials.gov processed this record on October 21, 2014