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临床试验/NCT00161694
NCT00161694终止不适用

Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
300
试验地点
1

研究概览

简要总结

The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double

入排标准

年龄范围
5 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen.

排除标准

  • Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus.
  • Any infant being maintained on narcotics for any reason will not be eligible for the study.
  • All infants with major congenital anomalies will be excluded.

研究者

申办方类型
Other

研究点 (1)

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