- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203436
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.
This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Ohio
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Cincinnati, Ohio, United States, 45267
- Cincinnati Children's Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee
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Texas
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Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center at Dallas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
- Median pulse oxygen saturation <94% in room air
- Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator
Exclusion Criteria:
- No fatal congenital anomaly or congenital eye anomaly
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supplemental Oxygen
Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.
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Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.
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Active Comparator: Conventional Oxygen
Conventional oxygenation at a pulse oximetry target of 89% to 94%.
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Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
Time Frame: 3 months of age
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Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
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3 months of age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Dale L. Phelps, MD, University of Rochester
- Principal Investigator: Neal L. Oden, PhD, The Emmes Company, LLC
- Principal Investigator: Cynthia Cole, MD, Tufts Medical Center
- Principal Investigator: Richard E. McClead, MD, Ohio State University
- Study Director: Alan R. Spitzer, MD, Thomas Jefferson University
- Principal Investigator: J. David Bradford, MD, Arkansas Childrens Hospital
- Principal Investigator: Charles C. Barr, MD, University of Louisville
- Principal Investigator: David Easa, MD, Kapiolani Medical Center
- Principal Investigator: Beverly S. Brozanski, MD, Magee-Womena Hospital
- Principal Investigator: Robert Gordon, MD, Tulane University
- Principal Investigator: Pamela A. Weber, MD, SUNY Stonybrook
- Principal Investigator: Frank W. Kokomoor, MD, Akron Childrens Hospital
- Principal Investigator: Michael J. Shapiro, MD, University of Illinois at Chicago
- Principal Investigator: Raul C. Banagale, MD, Legacy Emanual Childrens Hospital
- Principal Investigator: Mitchell E. Stern, MD, Sheridan Childrens Healthcare Services
- Principal Investigator: Mark W. Preslan, MD, University of Maryland
- Principal Investigator: Shephen S. Feman, MD, Vanderbilt University
- Principal Investigator: James Kirk, DO, University of Florida
- Principal Investigator: Terri L. Young, MD, Fairview University Medical Center
- Principal Investigator: Mary Anne McCaffree, MD, Childrens Hospital of Oklahoma
- Principal Investigator: Malini Satish, MD, Childrens Medical Center of Northwest Ohio
- Principal Investigator: Patrick J. Droste, MD, Cook Institute for Research and Education
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Infant, Newborn, Diseases
- Body Weight
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Sensation Disorders
- Infant, Premature, Diseases
- Vision Disorders
- Retinal Diseases
- Premature Birth
- Birth Weight
- Retinopathy of Prematurity
- Blindness
Other Study ID Numbers
- NICHD-NRN-0010
- U10HD021385 (U.S. NIH Grant/Contract)
- U10HD027851 (U.S. NIH Grant/Contract)
- U10HD027853 (U.S. NIH Grant/Contract)
- U10HD027856 (U.S. NIH Grant/Contract)
- U10HD027871 (U.S. NIH Grant/Contract)
- U10HD027880 (U.S. NIH Grant/Contract)
- U10HD027904 (U.S. NIH Grant/Contract)
- U10HD040689 (U.S. NIH Grant/Contract)
- U10HD021415 (U.S. NIH Grant/Contract)
- M01RR000070 (U.S. NIH Grant/Contract)
- M01RR000054 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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