Status:
NOT_YET_RECRUITING
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Lead Sponsor:
Carag AG
Conditions:
NEC
Eligibility:
All Genders
1-7 years
Phase:
NA
Brief 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 t...
Detailed Description
Each child will be measured over a time span of three days with the novel NIRS device. 1. A two-hour measurement is performed in measurement phase 1 2. Additionally, the sensor will be placed five ti...
Eligibility Criteria
Inclusion
- 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
- 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,
- 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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05278247
Start Date
February 1 2026
End Date
December 31 2027
Last Update
November 28 2025
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