NCT05842876已完成不适用
Renal NIRS Monitoring to Detect Coarctation of the Aorta - A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Percent of time monitored
研究概览
简要总结
The goal of this observational study is to determine the feasibility of renal Near Infrared Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation of the aorta (CoA). The main questions it aims to answer are:
- whether continuous renal NIRS monitoring is feasible;
- whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than current standard monitoring; and,
- whether participants who develop CoA will spend a smaller proportion of time within the normal range than patients who do not have CoA.
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delivered at ≥ 35 weeks of gestation
- •<12 hours of age
- •Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU
- •Diagnosed as at risk for CoA
排除标准
- •Major congenital anomalies of the kidney
- •Attending physician's discretion to not place sensors due to clinical concerns
- •In the researcher's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life
- •Primary Caregiver Inclusion Criteria:
- •Able to understand and the willing to sign a written informed consent document
- •Willing to comply with all study procedures and be available for the duration of the study
- •Birth parent (i.e., the parent who gave birth to the baby) who is the primary caregiver of a neonate who is eligible to participate in study
- •Agrees to enroll neonate into study
- •Aged 15 years or older
- •Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible for the study. They must also meet the following criteria:
- •Require an "arch watch care plan" as a results of prenatal ultrasonography findings
- •Agree to enroll offspring into the study at birth
- •Primary Caregiver Exclusion Criteria:
- •Subject is unable to provide informed consent, including subjects who are in foster care and subjects within state custody
- •Pregnant woman who does not plan to maintain custody of the child after birth, such as instances of adoption or surrogacy
- •Newborn Nursery Nursing Staff:
- •All Newborn Nursery nursing staff at Meriter Hospital, Inc.'s Newborn Nursery are eligible to participate
结局指标
主要结局
Percent of time monitored
时间窗: Up to 2 weeks post-delivery, on average
Amount of time continuously monitored will be calculated
Count of adverse and unexpected events
时间窗: Up to 2 weeks post-delivery
All adverse and unexpected events will be recorded
次要结局
- Parent/caregiver satisfaction with renal NIRS monitoring(Up to 2 weeks post-delivery, on average)
- Change in nursing satisfaction with renal NIRS monitoring(Study start to one year later)
- Renal oxygen trends(Through study completion, approximately 1 year)
研究者
研究点 (2)
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