Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

649 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-02-28

Study Completion Date

1999-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Retinopathy of Prematurity Blindness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplemental Oxygen

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

Group Type EXPERIMENTAL

Supplemental Oxygen Management

Intervention Type PROCEDURE

Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.

Conventional Oxygen

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

Group Type ACTIVE_COMPARATOR

Conventional Oxygen Management

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Conventional Oxygen Management

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Rochester

Principal Investigators

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Dale L. Phelps, MD

Role: STUDY_DIRECTOR

University of Rochester

Neal L. Oden, PhD

Role: PRINCIPAL_INVESTIGATOR

The Emmes Company, LLC

Cynthia Cole, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Richard E. McClead, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Alan R. Spitzer, MD

Role: STUDY_DIRECTOR

Thomas Jefferson University

J. David Bradford, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Childrens Hospital

Charles C. Barr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Womens and Infants Hospital

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

James A. Lemons, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

David K. Stevenson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee at Memphis

Jon E. Tyson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

David Easa, MD

Role: PRINCIPAL_INVESTIGATOR

Kapiolani Medical Center

Beverly S. Brozanski, MD

Role: PRINCIPAL_INVESTIGATOR

Magee-Womena Hospital

Robert Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Pamela A. Weber, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Stonybrook

Frank W. Kokomoor, MD

Role: PRINCIPAL_INVESTIGATOR

Akron Childrens Hospital

Michael J. Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Raul C. Banagale, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Emanual Childrens Hospital

Mitchell E. Stern, MD

Role: PRINCIPAL_INVESTIGATOR

Sheridan Childrens Healthcare Services

Mark W. Preslan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Shephen S. Feman, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

James Kirk, DO

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Terri L. Young, MD

Role: PRINCIPAL_INVESTIGATOR

Fairview University Medical Center

Mary Anne McCaffree, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital of Oklahoma

Malini Satish, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Medical Center of Northwest Ohio

Patrick J. Droste, MD

Role: PRINCIPAL_INVESTIGATOR

Cook Institute for Research and Education

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 10654946 (View on PubMed)