Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Trial ID or NCT#

NCT01203436

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Eligibility Criteria

Ages Eligible for Study: Younger than 48 Hours
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * No fatal congenital anomaly or congenital eye anomaly

Investigator(s)

David K. Stevenson, M.D.