| ID | Type | Description | Link |
|---|---|---|---|
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD021415 | U.S. NIH Grant/Contract | View source | |
| U10HD040689 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027871 | U.S. NIH Grant/Contract | View source | |
| M01RR000054 | U.S. NIH Grant/Contract | View source | |
| M01RR000070 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| National Eye Institute (NEI) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
| Delta Gamma Sorority |
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The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental Oxygen | Experimental | Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. |
|
| Conventional Oxygen | Active Comparator | Conventional oxygenation at a pulse oximetry target of 89% to 94%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental Oxygen Management | Procedure | Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery | Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery | 3 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale L. Phelps, MD | University of Rochester | Study Director |
| 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 | Principal Investigator |
| Alan R. Spitzer, MD | Thomas Jefferson University | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10654946 | Result | Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| UNKNOWN |
| Rhea and Raymond White | UNKNOWN |
| Research to Prevent Blindness | OTHER |
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| Conventional Oxygen Management | Procedure | Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation. |
|
| 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 | 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 | Principal Investigator |
| New Haven |
| Connecticut |
| 06504 |
| United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012178 | Retinopathy of Prematurity |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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