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

• ClinicalTrials.gov Identifier: NCT01203436
• Recruitment Status: Completed
• First Posted: September 16, 2010
• Last Update Posted: June 8, 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
• Information provided by: NICHD Neonatal Research Network

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.

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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 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
• 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

More Information

Additional Information:

NICHD Neonatal Research Network 

Publications of Results:

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310.

• 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
• 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:

Blindness; Retinal Diseases; Retinopathy of Prematurity; Premature Birth; Birth Weight; Eye Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight; Infant, Premature, Diseases; Infant, Newborn, Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases