Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Information source: Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Development of Side Effects From Betaxolol
Intervention: Betaxolol (Drug); topical betaxolol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Smith-Kettlewell Eye Research Institute
Summary
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of
prematurity.
Clinical Details
Official title: Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: development of apnea and or bradycardia
Secondary outcome: development of ROP requiring 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.
Eligibility
Minimum age: 32 Weeks.
Maximum age: 32 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- <1251 grms birth weight
Exclusion Criteria:
- ocular defect
Locations and Contacts
Additional Information
Starting date: April 2011
Last updated: January 2, 2013
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