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

ConditionNEC

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-7

SponsorCarag AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm infants with Gestational age less than 35 0/7 weeks

Signed Informed consent of the legal representative(s) is received after being informed. The consent form is signed by one legal representative, which is likely to be either the mother or the father. Only married fathers or those listed on the birth certificate are considered under UK regulations. In the case of non-married father, the mother must provide consent.

Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.

Disqualifiers

Injured, hypersensitive or bruised skin present on the abdomen,

Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation,

Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors,

Severe Congenital malformations,

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: single arm for all subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

3 days

Secondary outcomes

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.

Time frame

3 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carag AG

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: