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

This study has been completed.
Hadassah Medical Organization
Laniado Hospital
Nazareth Hospital
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
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

  Baseline Characteristics
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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  
Number of Participants  
[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.   Safety Issue:   Yes

  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
No text entered.

  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 )
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