NCT01203436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1994

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1994

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

5.1 years

First QC Date

September 15, 2010

Last Update Submit

June 3, 2015

Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureRetinopathy of PrematurityBlindness

Keywords

NICHD Neonatal Research NetworkVery Low Birth Weight (VLBW)Extremely Low Birth Weight (ELBW)Prematurity

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months of age

Study Arms (2)

Supplemental Oxygen

EXPERIMENTAL

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

Procedure: Supplemental Oxygen Management

Conventional Oxygen

ACTIVE COMPARATOR

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

Procedure: Conventional Oxygen Management

Interventions

Supplemental Oxygen ManagementPROCEDURE

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

Supplemental Oxygen
Conventional Oxygen ManagementPROCEDURE

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

Conventional Oxygen

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No fatal congenital anomaly or congenital eye anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • 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.

    PMID: 10654946RESULT

Related Links

MeSH Terms

Conditions

Premature BirthRetinopathy of PrematurityBlindness

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRetinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dale L. Phelps, MD

    University of Rochester

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

  • Alan R. Spitzer, MD

    Thomas Jefferson University

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

February 1, 1994

Primary Completion

March 1, 1999

Study Completion

March 1, 1999

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(9)