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

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ClinicalTrials.gov Identifier: NCT01238471
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : June 10, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
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%
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propranolol Oral Sucrose 5%
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Propranolol Oral Sucrose 5% Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 10 participants 20 participants
60.9  (4.9) 64.4  (10.5) 62.6  (7.7)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
4
  40.0%
9
  45.0%
Male
5
  50.0%
6
  60.0%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy
Hide Description

If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.

Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina.

Time Frame propranolol therapy for up 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Oral Sucrose 5%
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: cases
4 8
2.Secondary Outcome
Title Safety of Propranolol Therapy in Premature Infants
Hide Description Close monitoring for possible side effects of propranolol in premature infants
Time Frame 4 weeks of propranolol therapy in premature infants
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Oral Sucrose 5%
Hide Arm/Group Description

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

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

All-Cause Mortality
Propranolol Oral Sucrose 5%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Propranolol Oral Sucrose 5%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Cardiac disorders     
bradycardia  [1]  0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
none had bradycardia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Oral Sucrose 5%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
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
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