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临床试验/NCT00665769
NCT00665769终止不适用

Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2008年6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
103
试验地点
2
主要终点
The effect of hypercapnia vs. normocapnia on the development of Grade II-IV intraventricular hemorrhage/periventricular leukomalacia (severe brain injury) and/or death

研究概览

简要总结

Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury.

  1. Since most of these infants require ventilators (respirators) to survive, we will investigate how 2 different methods of ventilation affect brain injury. We believe that a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain blood flow and lead to less bleeding in the brain.
  2. We will also examine how treatment for low blood pressure in these infants may be associated with brain injury. We believe that most very premature infants with low blood pressure actually do worse if they are treated. We think that by allowing the infants to normalize blood pressure on their own will allow them to stabilize blood flow to the brain leading to less intraventricular hemorrhage.
  3. In 10 premature infants with severe brain bleeding, we have developed a simple technique to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infants are at highest risk of developing intraventricular hemorrhage and who could most benefit from interventions that would reduce disturbances of brain blood flow.

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
1 Minute 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • ventilated ELBW (401-1000 grams) infants
  • 23 to 30 weeks' gestation
  • umbilical arterial catheter placed during newborn resuscitation

排除标准

  • presence of complex congenital anomalies or chromosomal abnormality
  • presence of central nervous system malformation
  • infants with hydrops fetalis
  • infants in extremis
  • infants with early (<3 hour of age) intraventricular hemorrhage

结局指标

主要结局

The effect of hypercapnia vs. normocapnia on the development of Grade II-IV intraventricular hemorrhage/periventricular leukomalacia (severe brain injury) and/or death

时间窗: During first 2 weeks of life (intraventricular hemorrhage and/or death), initial hospitalization for periventricular leukomalacia

次要结局

  • The effect of hypercapnia vs. normocapnia on the development of chronic lung disease (requirement of supplemental oxygen at 36 weeks corrected gestational age)(By 36 weeks corrected gestational age.)
  • The effect of hypercapnia vs. normocapnia on abnormal results from MRIs(at term-equivalent age)
  • The effect of hypercapnia vs. normocapnia on the development of pulmonary hemorrhage(During the initial hospitalization)

研究者

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

Christopher J. Rhee, MD, MS

Professor of Pediatrics and Obstetrics and Gynecology

Baylor University

研究点 (2)

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