STOP-ROP: Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Study Details

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

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 :

Feb 1, 1994

Actual Primary Completion Date :

Mar 1, 1999

Actual Study Completion Date :

Mar 1, 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.

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 48 Hours

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Yale University	New Haven	Connecticut	United States	06504
3	Emory University	Atlanta	Georgia	United States	30303
4	Indiana University	Indianapolis	Indiana	United States	46202
5	Wayne State University	Detroit	Michigan	United States	48201
6	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
7	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
8	University of Tennessee	Memphis	Tennessee	United States	38163
9	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