Not Yet RecruitingNot Applicable

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

50 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range1 Day – 7 Days

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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,
✕. 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,

What they're measuring

Performance of the CTOM system

Timeframe: 3 days

Trial details

NCT IDNCT05278247

SponsorCarag AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Jane Berrington, Dr.

+44 (0) 191 282 janet.berrington1@nhs.net

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