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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:
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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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
  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

Total Total of all reporting groups

Baseline Measures
    Propranolol     Oral Sucrose 5%     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: days]
Mean ± Standard Deviation
  60.9  ± 4.9     64.4  ± 10.5     62.6  ± 7.7  
Age  
[units: participants]
     
<=18 years     10     10     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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


Other Adverse Events
    Propranolol     Oral Sucrose 5%  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/10     0/10  



  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