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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
Results First Submitted: May 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Retinopathy of Prematurity
Interventions: Drug: propranolol
Drug: sucrose 5%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Propranolol

Oral propranolol for premature infants allocated to this arm by randomization

propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks

Oral Sucrose 5%

Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization

sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks


Participant Flow:   Overall Study
    Propranolol   Oral Sucrose 5%
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy   [ Time Frame: propranolol therapy for up 4 weeks ]

2.  Secondary:   Safety of Propranolol Therapy in Premature Infants   [ Time Frame: 4 weeks of propranolol therapy in premature infants ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Imad Makhoul
Organization: Rambam Medical Center
phone: 972-4-8542219
e-mail: makhoul@rambam.health.gov.il



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