Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP)
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ClinicalTrials.gov Identifier: NCT01203436 |
Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : June 8, 2015
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Condition or disease | Intervention/treatment | Phase |
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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Retinopathy of Prematurity Blindness | Procedure: Supplemental Oxygen Management Procedure: Conventional Oxygen Management | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 649 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity |
Study Start Date : | February 1994 |
Actual Primary Completion Date : | March 1999 |
Actual Study Completion Date : | March 1999 |

Arm | Intervention/treatment |
---|---|
Experimental: Supplemental Oxygen
Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.
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Procedure: Supplemental Oxygen Management
Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints. |
Active Comparator: Conventional Oxygen
Conventional oxygenation at a pulse oximetry target of 89% to 94%.
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Procedure: Conventional Oxygen Management
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation. |
- Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery [ Time Frame: 3 months of age ]Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

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Ages Eligible for Study: | up to 48 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203436
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06504 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30303 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Ohio | |
Cincinnati Children's Medical Center | |
Cincinnati, Ohio, United States, 45267 | |
United States, Rhode Island | |
Brown University, Women & Infants Hospital of Rhode Island | |
Providence, Rhode Island, United States, 02905 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75235 |
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: | William Oh, MD | Brown University, Womens and Infants Hospital | |
Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
Principal Investigator: | James A. Lemons, MD | Indiana University | |
Principal Investigator: | David K. Stevenson, MD | Stanford University | |
Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee at Memphis | |
Principal Investigator: | Jon E. Tyson, MD MPH | University of Texas | |
Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
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, College Park | |
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 of Results:
Responsible Party: | Dale L. Phelps/ Lead Principal Investigator, University of Rochester |
ClinicalTrials.gov Identifier: | NCT01203436 |
Obsolete Identifiers: | NCT00000141 |
Other Study ID Numbers: |
NICHD-NRN-0010 U10HD027904 ( U.S. NIH Grant/Contract ) U10HD027851 ( U.S. NIH Grant/Contract ) U10HD027856 ( U.S. NIH Grant/Contract ) U10HD027880 ( U.S. NIH Grant/Contract ) U10HD027853 ( U.S. NIH Grant/Contract ) U10HD021415 ( U.S. NIH Grant/Contract ) U10HD040689 ( U.S. NIH Grant/Contract ) U10HD021385 ( U.S. NIH Grant/Contract ) U10HD027871 ( U.S. NIH Grant/Contract ) M01RR000054 ( U.S. NIH Grant/Contract ) M01RR000070 ( U.S. NIH Grant/Contract ) |
First Posted: | September 16, 2010 Key Record Dates |
Last Update Posted: | June 8, 2015 |
Last Verified: | June 2015 |
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
Blindness Retinal Diseases Retinopathy of Prematurity Premature Birth Birth Weight Eye Diseases Body Weight Obstetric Labor, Premature |
Obstetric Labor Complications Pregnancy Complications Infant, Premature, Diseases Infant, Newborn, Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases |