Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Last updated: June 3, 2015
Sponsor: NICHD Neonatal Research Network
Overall Status: Completed

Phase

2/3

Condition

Vision Loss

Retina

Myopic Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT01203436
NICHD-NRN-0010
U10HD027851
M01RR000070
U10HD021415
U10HD027904
U10HD021385
U10HD027871
U10HD027880
U10HD040689
U10HD027853
U10HD027856
M01RR000054
  • Ages < 48
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants with prethreshold retinopathy of prematurity, confirmed by 2 certifiedophthalmologic exams

  • Median pulse oxygen saturation <94% in room air

  • Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator

Exclusion

Exclusion Criteria:

  • No fatal congenital anomaly or congenital eye anomaly

Study Design

Total Participants: 649
Study Start date:
February 01, 1994
Estimated Completion Date:
March 31, 1999

Study 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.

Connect with a study center

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06504
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Tennessee

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

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