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

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. Identifier: NCT01238471
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : June 10, 2014
Last Update Posted : June 26, 2014
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
Information provided by (Responsible Party):
Rambam Health Care Campus

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

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

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

Total Total of all reporting groups

Baseline Measures
   Propranolol   Oral Sucrose 5%   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
[Units: Days]
Mean (Standard Deviation)
 60.9  (4.9)   64.4  (10.5)   62.6  (7.7) 
[Units: Participants]
<=18 years   10   10   20 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Participants]
Female   5   4   9 
Male   5   6   11 
Region of Enrollment 
[Units: Participants]
Israel   10   10   20 

  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

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
No text entered.

  More Information

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

Responsible Party: Rambam Health Care Campus 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