NCT01660620

Brief Summary

We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
Last Updated

January 3, 2013

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

August 6, 2012

Last Update Submit

January 2, 2013

Conditions

Development of Side Effects From Betaxolol

Keywords

betaxolol/ retinopathy of prematurity

Outcome Measures

Primary Outcomes (1)

  • development of apnea and or bradycardia

    babies were monitored and HR/RR monitored and recorded by masked observers, periodically

    3 weeks

Secondary Outcomes (1)

  • development of ROP requiring treatment

    7 weeks

Study Arms (2)

betaxolol

EXPERIMENTAL

betaxolol 0.25% 2 per day for 3 weeks

Drug: Betaxolol

placebo

PLACEBO COMPARATOR

masked labeling also 2 per day administration

Drug: topical betaxolol

Interventions

BetaxololDRUG
betaxolol
topical betaxololDRUG

given topically

placebo

Eligibility Criteria

Age32 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \<1251 grms birth weight

You may not qualify if:

  • ocular defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Betaxolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrator

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

April 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 3, 2013

Record last verified: 2012-08