Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia
研究概览
简要总结
The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.
Researchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.
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
- 1 Minute 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delivered at <32 weeks' gestation
- •≤72 hours of age
- •Inpatient at Meriter Hospital, Inc. NICU
- •At least one parent/guardian is able to provide parental permission in English or Spanish
排除标准
- •Major congenital anomalies of kidney
- •Attending physician's discretion to not place NIRS sensors due to clinical concerns
- •In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life
- •Birth parent aged <18
研究组 & 干预措施
Neonates with PDA
干预措施: Near Infrared Spectroscopy (Device)
结局指标
主要结局
Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia
时间窗: Days 1 to 7 of age
Measured through continuous renal near infrared spectroscopy (NIRS) monitoring in neonates with a PDA to those without. Echos will be obtained every 48 hours during the first 7 days of age for a maximum of 3. RSO2 will be recorded until 7 days of age.
次要结局
- Correlation of Iowa PDA score to kidney hypoxia(Days 1-7 of age)
- Correlation between urinary biomarkers and Iowa PDA score(Days 1-7 of life)
- Correlation between rates of hypertension and Iowa PDA score(Duration of hospitalization, up to 6 months)
- Correlation between rates of acute kidney injury (AKI) and Iowa PDA score(Duration of hospitalization, up to 6 months)