Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 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.
研究组 & 干预措施
Observational Arm
Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time.
干预措施: Near-infrared spectroscopy (NIRS) utilization (Device)
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