Back to resultsTopical Betaxolol for the Prevention of Retinopathy of Prematurity
Primary Purpose
Development of Side Effects From Betaxolol
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Betaxolol
topical betaxolol
Sponsored by
About this trial
This is an interventional prevention trial for Development of Side Effects From Betaxolol focused on measuring betaxolol/ retinopathy of prematurity
Eligibility Criteria
Inclusion Criteria:
- <1251 grms birth weight
Exclusion Criteria:
- ocular defect
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
betaxolol
placebo
Arm Description
betaxolol 0.25% 2 per day for 3 weeks
masked labeling also 2 per day administration
Outcomes
Primary Outcome Measures
development of apnea and or bradycardia
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
Secondary Outcome Measures
development of ROP requiring treatment
Type I ROP was used as a secondary outcome measure
Full Information
NCT ID
NCT01660620
First Posted
August 6, 2012
Last Updated
January 2, 2013
Sponsor
Smith-Kettlewell Eye Research Institute
Collaborators
Ohio State University, University of Minnesota, University of Oklahoma, The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT01660620
Brief Title
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Official Title
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Smith-Kettlewell Eye Research Institute
Collaborators
Ohio State University, University of Minnesota, University of Oklahoma, The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
Detailed Description
The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development of Side Effects From Betaxolol
Keywords
betaxolol/ retinopathy of prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
betaxolol
Arm Type
Experimental
Arm Description
betaxolol 0.25% 2 per day for 3 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
masked labeling also 2 per day administration
Intervention Type
Drug
Intervention Name(s)
Betaxolol
Intervention Type
Drug
Intervention Name(s)
topical betaxolol
Intervention Description
given topically
Primary Outcome Measure Information:
Title
development of apnea and or bradycardia
Description
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
development of ROP requiring treatment
Description
Type I ROP was used as a secondary outcome measure
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
<1251 grms birth weight
Exclusion Criteria:
ocular defect
12. IPD Sharing Statement
Learn more about this trial
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
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