Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 7
- 主要终点
- Mortality Before Hospital Discharge
研究概览
简要总结
Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.
This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight <= 1250 grams
- •indwelling arterial catheter in place
- •age <24 hours old
排除标准
- •lethal chromosomal abnormality
- •major congenital anomaly
- •skin integrity insufficient to allow placement of NIRS sensors
- •decision to not provide full intensive care
结局指标
主要结局
Mortality Before Hospital Discharge
时间窗: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.
Participants will be followed for the outcome of death prior to hospital discharge.
Severe Central Nervous System (CNS) Morbidity
时间窗: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life
Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.
次要结局
未报告次要终点
研究者
Valerie Chock, M.D., M.S. Epi
Principle Investigator
Stanford University