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
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
Treatments tested in this trial
- NIRS
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov