Resonance Raman Spectroscopy Detects Peripheral Tissue Oxygen Deprivation in Very Low Birth Weight Infants With Umbilical Artery Catheters
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants with a Significant Adverse Event (SAEs)
研究概览
简要总结
Umbilical artery catheters (UACs) are associated with significant morbidity in preterm neonates however are necessary for the management of this high risk population. UACs have been linked to serious adverse events (SAEs) including arterial thrombosis, necrotizing enterocolitis, limb ischemia, and renal failure. Resonance Raman Spectroscopy (RRS), raman for short, is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues.
In this prospective, observational study, daily measurements of StO2 of low birth weight neonates using raman spectroscopy will be correlated with UACs.The study team hypothesizes that raman can detect changes in peripheral tissue oxygenation in the ipsilateral extremity to the UAC and that raman is more sensitive at detecting changes in peripheral tissue oxygenation then common metrics used to monitor neonatal hemodynamics. If successful, this study would demonstrate that raman can be used as an early marker of tissue oxygen deprivation in neonates with UACs and maybe used to guide management in other clinical scenarios where StO2 is affected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate Inclusion Criteria:
- •Birth weight less than 1500 grams.
- •Admitted to the NICU.
- •UAC placed on admission.
- •Mother Inclusion Criteria:
- •Admitted to the labor and delivery or antenatal floors with reasonable chance of delivery of a neonate weighing less than 1500 grams as determined by the obstetrics team.
排除标准
- •Neonate Exclusion Criteria:
- •Neonates with congenital heart defects or major congenital anomalies such as known or suspected inborn errors of metabolism, ambiguous genitalia, neural tube defects, malignancy, abdominal wall defects, airway defects and chromosomal anomalies.
- •Mother Exclusion Criteria:
- •Mother is pregnant with fetus with congenital heart defect or major congenital anomaly as described above.
结局指标
主要结局
Number of participants with a Significant Adverse Event (SAEs)
时间窗: Week 1
SAEs will be a composite of any of the following: lower extremity ischemia, Acute Kidney Injury (AKI), Neo natal Necrotizing Enterocolitis (NEC) or death abstracted from the medical record and/or bedside nurse interview, if necessary.
次要结局
未报告次要终点