Diagnosis of oxygen saturation in the abdomen of premature infants.
Conditions
Interventions
Group 1: Premature infants, without control group.
3 measurements are taken on the abdomen with the medical device. 5 times 1 minute, 2 hours, then a 70 hour long term measurement. The sensor remains
Sponsors
Carag AG
Eligibility
Sex/Gender
All
Age
1 Days to 7 Days
Inclusion criteria
Inclusion criteria: Patients fulfilling all of the following inclusion criteria may be enrolled in this investigation: 1. Preterm infants with GA less than 35 0/7 weeks 2. Day of life 1-5 at GA 30-35 0/7 weeks. Day of life 3-7 at GA 24-29 weeks. (Day of life 1 means the day after birth. Day of birth is day zero until midnight.) GA calculation: a) Naegele: counting the time back three months from the first day of the last menstrual period and then adding seven days and one year. b) Ultrasound biometry in the first trimenon: calculation of „crown rump length“ (CRL). I. Before WOG (in German: SSW) 10 II. Between WOG (in German: SSW)10 and 14 c) GA on a given date (eg in-vitro fertilization) 3. Signed Informed consent of the legal representatives is received after being informed. 4. Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.
Exclusion criteria
Exclusion criteria: The presence of any one of the following exclusion criteria will lead to exclusion of the participant: 1. Injured, hypersensitive or bruised skin present on the abdomen, 2. Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation, 3. Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors, 4. Severe Congenital malformations, 5. Clinical abdominal concerns, 6. Severe metabolic disorders, 7. Early onset sepsis, 8. 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, 9. The treatment of newborn jaundice with light during measurement time phase 1 and 2, 10. Previous enrolment into the current study, 11. Family members, employees and other dependent persons of the investigator, 12. Participation in another study with investigational drug/device within the preceding days and during the present study which may influence aStO2. 13. Known silicone allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We intend to investigate sensor handling on preterm infants and access the signal variability and reproducibility. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second objective of this study is safety. Therefore, this study comprises an extensive assessment of adverse events (AE). | — |
Countries
Germany
Contacts
Public ContactChristoph Fusch
Klinikum Nürnberg Süd
Outcome results
None listed