Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

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.

Conditions

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

Interventions

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.

PROCEDURE

Conventional Oxygen Management

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

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• National Eye Institute (NEI)

  collaborator NIH

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Delta Gamma Sorority

  collaborator UNKNOWN

• Rhea and Raymond White

  collaborator UNKNOWN

• Research to Prevent Blindness

  collaborator OTHER

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Dale L. Phelps, MD · University of Rochester

• Neal L. Oden, PhD · The Emmes Company, LLC

• Cynthia Cole, MD · Tufts Medical Center

• Richard E. McClead, MD · Ohio State University

• Alan R. Spitzer, MD · Thomas Jefferson University

• J. David Bradford, MD · Arkansas Childrens Hospital

• Charles C. Barr, MD · University of Louisville

• William Oh, MD · Brown University, Womens and Infants Hospital

• Barbara J. Stoll, MD · Emory University

• James A. Lemons, MD · Indiana University

• David K. Stevenson, MD · Stanford University

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Sheldon B. Korones, MD · University of Tennessee at Memphis

• Jon E. Tyson, MD MPH · University of Texas

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• David Easa, MD · Kapiolani Medical Center

• Beverly S. Brozanski, MD · Magee-Womena Hospital

• Robert Gordon, MD · Tulane University

• Pamela A. Weber, MD · SUNY Stonybrook

• Frank W. Kokomoor, MD · Akron Childrens Hospital

• Michael J. Shapiro, MD · University of Illinois at Chicago

• Raul C. Banagale, MD · Legacy Emanual Childrens Hospital

• Mitchell E. Stern, MD · Sheridan Childrens Healthcare Services

• Mark W. Preslan, MD · University of Maryland

• Shephen S. Feman, MD · Vanderbilt University

• James Kirk, DO · University of Florida

• Terri L. Young, MD · Fairview University Medical Center

• Mary Anne McCaffree, MD · Childrens Hospital of Oklahoma

• Malini Satish, MD · Childrens Medical Center of Northwest Ohio

• Patrick J. Droste, MD · Cook Institute for Research and Education

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-02-28

Primary Completion

1999-03-31

Completion

1999-03-31

Countries

• United States

Study Locations