Topical Betaxolol for the Prevention of Retinopathy of Prematurity

Phase 1

Completed

• Conditions: Development of Side Effects From Betaxolol
• Interventions: Drug: Betaxolol; Drug: topical betaxolol

• Registration Number: NCT01660620
• Lead Sponsor: Smith-Kettlewell Eye Research Institute

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• <1251 grms birth weight

Exclusion Criteria

• ocular defect

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
betaxolol	Betaxolol	betaxolol 0.25% 2 per day for 3 weeks
placebo	topical betaxolol	masked labeling also 2 per day administration

Primary Outcome Measures

Name	Time	Method
development of apnea and or bradycardia	3 weeks	babies were monitored and HR/RR monitored and recorded by masked observers, periodically

Secondary Outcome Measures

Name	Time	Method
development of ROP requiring treatment	7 weeks	Type I ROP was used as a secondary outcome measure