Topical Betaxolol for the Prevention of Retinopathy of Prematurity
January 2, 2013 updated by: William V Good, MD, Smith-Kettlewell Eye Research Institute
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- <1251 grms birth weight
Exclusion Criteria:
- ocular defect
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: betaxolol
betaxolol 0.25% 2 per day for 3 weeks
|
|
|
Placebo Comparator: placebo
masked labeling also 2 per day administration
|
given topically
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
development of apnea and or bradycardia
Time Frame: 3 weeks
|
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
development of ROP requiring treatment
Time Frame: 7 weeks
|
Type I ROP was used as a secondary outcome measure
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
August 6, 2012
First Submitted That Met QC Criteria
August 7, 2012
First Posted (Estimate)
August 8, 2012
Study Record Updates
Last Update Posted (Estimate)
January 3, 2013
Last Update Submitted That Met QC Criteria
January 2, 2013
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Retinal Diseases
- Premature Birth
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Betaxolol
Other Study ID Numbers
- 108298
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.