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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
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Eye Institute (NEI)
National Institute of Nursing Research (NINR)
Delta Gamma Sorority
Rhea and Raymond White
Research to Prevent Blindness
Information provided by:
NICHD Neonatal Research Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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

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 : 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Supplemental Oxygen
Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.
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%.
Procedure: Conventional Oxygen Management
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.



Primary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
National Eye Institute (NEI)
National Institute of Nursing Research (NINR)
Delta Gamma Sorority
Rhea and Raymond White
Research to Prevent Blindness
Investigators
Study Director: Dale L. Phelps, MD University of Rochester
Principal Investigator: Neal L. Oden, PhD The EMMES Corporation
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
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

Additional Information:
Publications of Results:
Responsible Party: Dale L. Phelps/ Lead Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01203436     History of Changes
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

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity

Additional relevant MeSH terms:
Retinal Diseases
Birth Weight
Premature Birth
Retinopathy of Prematurity
Blindness
Eye Diseases
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases