Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird) (NCT05278247) | Clinical Trial Compass
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 range
1 Day – 7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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,