NCT01203436

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 649 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1994-02-01
• Primary completion: 1999-03-01
• Completion: 1999-03-01
• First posted: 2010-09-16
• Last updated: 2015-06-08

Locations

9 sites across 1 country: United States