NEC Clinical Trial
Official title:
An Open Single-center Study in England to Assess Safety and Performance of a NIRS System to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2). Near infrared spectroscopy (NIRS) is a technique available to non-invasively and safely monitor the tissue oxygenation status (StO2), which can be beneficial or live saving for this fragile patient population. Unfortunately, traditional NIRS devices show a broad variability when applied to the abdomen (Bailey & Mally 2016). The novel device is designed especially for application of NIRS on the abdomen of preterm infants.
Each child will be measured over a time span of three days with the novel NIRS device. 1. A two-hour measurement is performed in measurement phase 1 2. Additionally, the sensor will be placed five times onto the abdomen for 1-minute measurements, which constitutes measurement phase 2. 3. The final measurement phase 3 lasts for up to 70 hours. A total of two ultrasound (US) examination on the abdomen are performed during the first two measurement phases to assess the presence of air and stool in the abdomen. Additional assessment of SpO2 is performed throughout. Aside from the US and SpO2 measurement, no additional procedures will be performed. The NIRS measurement will not disturb necessary clinical and nursing procedures. ;
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