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Topical Betaxolol for the Prevention of Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT01660620
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : January 3, 2013
Sponsor:
Collaborators:
Ohio State University
University of Minnesota - Clinical and Translational Science Institute
University of Oklahoma
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
William V Good, MD, Smith-Kettlewell Eye Research Institute

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

Condition or disease Intervention/treatment Phase
Development of Side Effects From Betaxolol Drug: Betaxolol Drug: topical betaxolol Phase 1

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  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Study Start Date : April 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011


Arm Intervention/treatment
Experimental: betaxolol
betaxolol 0.25% 2 per day for 3 weeks
Drug: Betaxolol
Placebo Comparator: placebo
masked labeling also 2 per day administration
Drug: topical betaxolol
given topically




Primary Outcome Measures :
  1. development of apnea and or bradycardia [ Time Frame: 3 weeks ]
    babies were monitored and HR/RR monitored and recorded by masked observers, periodically


Secondary Outcome Measures :
  1. development of ROP requiring treatment [ Time Frame: 7 weeks ]
    Type I ROP was used as a secondary outcome measure



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Ages Eligible for Study:   32 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • <1251 grms birth weight

Exclusion Criteria:

  • ocular defect

Responsible Party: William V Good, MD, Administrator, Smith-Kettlewell Eye Research Institute
ClinicalTrials.gov Identifier: NCT01660620     History of Changes
Other Study ID Numbers: 108298
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: August 2012

Keywords provided by William V Good, MD, Smith-Kettlewell Eye Research Institute:
betaxolol/ retinopathy of prematurity

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Betaxolol
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action