Trials / Not Yet Recruiting

Not Yet RecruitingNCT05278247

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

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 50 (estimated)

Sponsor: Carag AG · Industry
Sex: All
Age: 1 Day – 7 Days
Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NIRS	Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants

Timeline

Start date: 2026-02-01
Primary completion: 2027-09-30
Completion: 2027-12-31
First posted: 2022-03-14
Last updated: 2025-11-28

Source: ClinicalTrials.gov record NCT05278247. Inclusion in this directory is not an endorsement.