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

Sponsor
Carag AG
Study ID
NCT05278247
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 7 Days
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: single arm for all subjects
    all subjects receive the same diagnostic measurement

Primary Outcome Measure

Performance of the CTOM system [ Time Frame: 3 days ]

Central Contacts

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