NCT04639583已完成不适用
Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Cerebral Regional Oxygen Saturation (cRSO2)
研究概览
简要总结
Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of "normal" values is different than those obtained at sea level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant must be <32 weeks' gestational age at time of delivery.
- •Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients.
- •Infants that require blood transfusions during the monitoring time may be included.
排除标准
- •Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow.
- •Infant born after placental abruption or concern for extreme blood loss immediately after birth.
- •Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery).
- •Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed.
- •Mothers/guardians that are <18 years of age will not be approached for consent.
- •Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study.
- •Any infant that is planned to be placed for adoption
- •Infant is greater than 24 hours of age at time of consent.
结局指标
主要结局
Cerebral Regional Oxygen Saturation (cRSO2)
时间窗: first 96 hours of life
Measure cRSO2 for the first 96 hours of life in infants born preterm.
次要结局
- Incidence of Major Complications of Prematurity(From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.)
研究者
Jessie R. Maxwell
Assistant Professor of Pediatrics and Neurosciences
University of New Mexico
研究点 (2)
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