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临床试验/NCT01203436
NCT01203436已完成2 期

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

NICHD Neonatal Research Network18 个研究点 分布在 1 个国家目标入组 649 人开始时间: 1994年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
649
试验地点
18
主要终点
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 48 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No fatal congenital anomaly or congenital eye anomaly

结局指标

主要结局

Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

时间窗: 3 months of age

Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

次要结局

未报告次要终点

研究者

发起方
NICHD Neonatal Research Network
申办方类型
Network

研究点 (18)

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