Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP)

June 3, 2015 updated by: NICHD Neonatal Research Network
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.

Study Overview

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

Enrollment (Actual)

649

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Yale University
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati Children's Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University, Women & Infants Hospital of Rhode Island
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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%.
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%.
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.

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
Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
3 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1994

Primary Completion (Actual)

March 1, 1999

Study Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

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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