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临床试验/NCT00845624
NCT00845624已完成不适用

DURATION OF TIME OUTSIDE, BELOW, AND ABOVE THE TARGETED Oxygen SATURATION RANGE In Preterm Infants

University of Virginia1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Retinopathy of prematurity

研究概览

简要总结

The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.

详细描述

All infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation admitted to our neonatal intensive care unit (NICU) were eligible for the study. All infants were placed on Nellcor N600 pulsoximetry. Saturation data in two-second sampling from N600 OXIMAX pulse oximeters (Covidian, CA) was collected using a modified Nellcor® Oxinet® III system (Covidian, CA and Cardiopulmonary, Milford, CT) Alarm limits were set at 83% and 93% while infants required oxygen supplementation and 85% to 100% when neonates were in room air. Desaturation events were defined as number of times the saturation fell below the low saturation limit set on the monitor (83% if oxygen requirement >21%, 85% if patient on room air). High saturation events were defined as the number of times the patient's saturation was above the upper saturation limit (93% if oxygen requirement >21%)

The data collection system summarized each day in tabular form including average SPO2, number of low and high SPO2 events, duration of events in minutes, and the percentage of time infants spent outside of the intended saturation range. Primary outcome was threshold ROP requiring laser ablation. Data on ROP was collected during hospitalization and after discharge until resolution of ROP by pediatric ophthalmologist blinded to the study results. Secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis, focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants <1500 grams or <32 weeks gestation

排除标准

  • 未提供

结局指标

主要结局

Retinopathy of prematurity

时间窗: 4 weeks to 52 weeks of life

次要结局

  • Time outside targeted saturation range(entire hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David A Kaufman

MD

University of Virginia

研究点 (1)

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