NEC(Songbird)NCT05278247
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
A study testing NIRS in people with NEC, run by Carag AG.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- NEC
- What is being tested?
- NIRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
- Clinical abdominal concerns
- Severe metabolic disorders,
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- Early onset sepsis,
- Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language,
- The treatment of newborn jaundice with light during measurement time phase 1 and 2,
- Previous enrolment into the current study,
- Family members, employees and other dependent persons of the investigator,
- Participation in another study with investigational drug/device within the preceding days and during the present study which may influence abdominal oxygen saturation.
- Known silicone allergy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
Each child will be measured over a time span of three days with the novel NIRS device.
- A two-hour measurement is performed in measurement phase 1
- Additionally, the sensor will be placed five times onto the abdomen for 1-minute measurements, which constitutes measurement phase 2.
- 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
- NEC
- Being tested
- NIRS
- Keywords
- abdominal NIRS for oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDiagnostic test
Performance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| single arm for all subjects | Experimental | all subjects receive the same diagnostic measurement Receives: Diagnostic Test: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Feb 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NECStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- confirmatory, open, single-arm, mono-centric
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carag AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaine Chapman, Study chair, lead NHS R&D contact
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278247
- Sponsor's protocol ID
- 2021.9635
- Acronym
- (Songbird)
- Status last verified
- Nov 2025
- First submitted
- 22 Feb 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05278247
- Acronym / sponsor ID
- (Songbird) / 2021.9635
- Conditions
- NEC
- Keywords
- abdominal NIRS for oxygen saturation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carag AGIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- A two-hour measurement is performed in measurement phase 1
- Additionally, the sensor will be placed five times onto the abdomen for 1-minute measurements, which constitutes measurement phase 2.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- confirmatory, open, single-arm, mono-centric
| Arm | Type | Receives |
|---|---|---|
| single arm for all subjects | Experimental | Diagnostic Test: NIRSall subjects receive the same diagnostic measurement |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
- Clinical abdominal concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSPerformance of a NIRS to monitor abdominal tissue oxygen saturation in preterm infants | Diagnostic test | single arm for all subjects |
Primary outcome
Performance of the CTOM system
Time frame: 3 days
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.
1 secondary outcome
Occurrence of adverse events is measured
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine Chapman study chair
lead NHS R&D contact
Questions about this trial
What is this clinical trial studying?
A study testing NIRS in people with NEC, run by Carag AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Berrington, Dr. (+44 (0) 191 282 ext. 5197, janet.berrington1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the CTOM system (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.