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

Primary Purpose

Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Supplemental Oxygen Management
Conventional Oxygen Management
Sponsored by
NICHD Neonatal Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • Yale University
  • Emory University
  • Indiana University
  • Wayne State University
  • Cincinnati Children's Medical Center
  • Brown University, Women & Infants Hospital of Rhode Island
  • University of Tennessee
  • University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supplemental Oxygen

Conventional Oxygen

Arm Description

Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.

Conventional oxygenation at a pulse oximetry target of 89% to 94%.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 15, 2010
Last Updated
June 3, 2015
Sponsor
NICHD Neonatal Research Network
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
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1. Study Identification

Unique Protocol Identification Number
NCT01203436
Brief Title
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
Acronym
STOP-ROP
Official Title
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 1994 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
March 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NICHD Neonatal Research Network
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Blindness
Keywords
NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale L. Phelps, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neal L. Oden, PhD
Organizational Affiliation
The Emmes Company, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Cole, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard E. McClead, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan R. Spitzer, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
J. David Bradford, MD
Organizational Affiliation
Arkansas Childrens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles C. Barr, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Oh, MD
Organizational Affiliation
Brown University, Womens and Infants Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara J. Stoll, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A. Lemons, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David K. Stevenson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheldon B. Korones, MD
Organizational Affiliation
University of Tennessee at Memphis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E. Tyson, MD MPH
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seetha Shankaran, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard A. Ehrenkranz, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Easa, MD
Organizational Affiliation
Kapiolani Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beverly S. Brozanski, MD
Organizational Affiliation
Magee-Womena Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Gordon, MD
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela A. Weber, MD
Organizational Affiliation
SUNY Stonybrook
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank W. Kokomoor, MD
Organizational Affiliation
Akron Childrens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Shapiro, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul C. Banagale, MD
Organizational Affiliation
Legacy Emanual Childrens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitchell E. Stern, MD
Organizational Affiliation
Sheridan Childrens Healthcare Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark W. Preslan, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shephen S. Feman, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Kirk, DO
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terri L. Young, MD
Organizational Affiliation
Fairview University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Anne McCaffree, MD
Organizational Affiliation
Childrens Hospital of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Malini Satish, MD
Organizational Affiliation
Childrens Medical Center of Northwest Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick J. Droste, MD
Organizational Affiliation
Cook Institute for Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10654946
Citation
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.
Results Reference
result
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network

Learn more about this trial

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

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