Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Completed · Phase 2/Phase 3

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

In brief

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.

Key facts

Study ID

NCT01203436

Run by

NICHD Neonatal Research Network

People needed

649

Starts

1994-02-01

Expected to finish

1999-03-01

Last updated by the study team

2015-06-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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