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
Results First Received: May 12, 2014  
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
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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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


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