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NOT YET RECRUITING
NCT05278247
NA

Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)

Sponsor: Carag AG

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

NIRS

Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants