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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm for all subjects | Experimental | all subjects receive the same diagnostic measurement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS | Diagnostic Test | Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the CTOM system | We intend to investigate sensor handling on preterm infants and record the signal variability and reproducibility. A measurement signal serves to analyse reproducibility, signal quality and different signal analysis methods. Abdominal oxygen tissue saturation will be calculated. The aStO2 values will be calculated with and without considering the presence of additional absorbers besides haemoglobin. The datasets to be analysed include three measurement series per subject from a total of at least 50 subjects. The planned analyses consist of descriptive statistics and time series analysis. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events is measured | AEs will be recorded and analyzed with regards to their relationship to the investigational device and the measurement procedure. The occurrence of adverse events, especially skin markers, will be measured. The study will compare AEs and SAEs from this study with documented AEs and SAEs employing NIRS devices. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Berrington, Dr. | Contact | +44 (0) 191 282 | 5197 | janet.berrington1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Elaine Chapman | lead NHS R&D contact | Study Chair |
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confirmatory, open, single-arm, mono-centric
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