Completed
NCT Number: NCT01660620
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.
Completed
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Notify MeKey information
Conditions
Age range
32 week–32 week
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- <1251 grms birth weight
Exclusion criteria
- ocular defect
Treatment and study plan
topical betaxolol
Druggiven topically
Primary outcomes
-
development of apnea and or bradycardia
Time frame: 3 weeks
babies were monitored and HR/RR monitored and recorded by masked observers, periodically
Secondary outcomes
-
development of ROP requiring treatment
Time frame: 7 weeks
Type I ROP was used as a secondary outcome measure
Sponsors and collaborators
Lead sponsor
Smith-Kettlewell Eye Research Institute
Other
Collaborators
- Ohio State University
- The University of Texas Health Science Center, Houston
- University of Minnesota
- University of Oklahoma
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Aug 8, 2012
- Registry last updated
- Jan 3, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.