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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238471
First Posted: November 10, 2010
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
Information provided by (Responsible Party):
Rambam Health Care Campus
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01238471     History of Changes
Other Study ID Numbers: 0479-09CTIL
Israeli Health Ministry ( Other Identifier: 1764/2117 Israeli Health Ministry Pharmaceutical Administration )
First Submitted: November 8, 2010
First Posted: November 10, 2010
Results First Submitted: May 12, 2014
Results First Posted: June 10, 2014
Last Update Posted: June 26, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents


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