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Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Sponsor: Carag AG
Summary
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.
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
Key Details
Gender
All
Age Range
1 Day - 7 Days
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02-01
Completion Date
2027-12-31
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
NIRS
Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants