P07 P74.2 P74.3 P74.4 P74.8
Conditions
Interventions
Group 1: Measurement of electrolytes in transdermal liquid
As part of the non-interventional EvalPreeMO study, the PreeMO system for the non-invasive measurement of electrolytes in transdermal fluid
during this period, both the replacement of the PreeMO system and a change in the application site are possible.
• Follow-up period after system removal: 24 hours
Sponsors
Klinik für Neugeborene, Kinder und Jugendliche, Klinikum Nürnberg Süd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Premature babies and babies born before the 37th week of pregnancy - Admission to the neonatal intensive care unit for intensive monitoring and care - Written consent from parents, legal guardians or legal representatives to participate in the study
Exclusion criteria
Exclusion criteria: - Congenital or acquired conditions that could affect the correct placement of the PreeMO system on the skin - Presence of skin lesions, wounds or infections at the intended application site - Abnormalities in skin condition that could affect transdermal electrolyte measurement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Correlation of measured values and trends between transdermal fluid and serum (method comparison). For quantification, the sensor’s measurement values during application are statistically analyzed and correlated with the serum values from routine laboratory examinations (see Sections 12 Biometry and 13 Data Management and Data Protection). • Comparison of the measured absolute values between transdermal measurements and serum measurements (Statement: "A serum hyponatremia can be directly detected in transdermal measurements."). • Comparison of changes/trends between transdermal measurements and serum values (Statement: "A decrease in serum sodium concentration is reflected in a decrease in transdermal sodium concentration."). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Ability of the textile fluid transport system to efficiently absorb the available amounts of transdermal fluid and deliver it to the multisensor. To quantify the absorption capacity of the fluid transport system for transdermal fluid, it is weighed before and after application on the patient. The difference represents the amount of fluid absorbed and retained in the absorber during the application period. • Ability of the multisensor to perform reliable and reproducible measurements of electrolyte concentrations for sodium, potassium, and chloride. For quantification, the continuous measurement values recorded during application are statistically analyzed (see Sections 12 Biometry and 13 Data Management and Data Protection). • Acceptance of the system among term-born infants as well as in the preterm infant patient population. Quantification is conducted via questionnaires for the study personnel and through an evaluation of the patient records. The acceptance criteria include: • General acceptance of the system at the application site by the patients Skin compatibility • Acceptance of the system by users and in clinical application: • Handling by medical staff: Quantification is conducted via questionnaires for the study personnel. • Integration into the clinical care routine without clinical decisions being made based solely on the measurement values: Evaluation is carried out through surveys of the ward staff. | — |
Countries
Germany
Contacts
Public ContactChristoph Fusch
Klinik für Neugeborene, Kinder und Jugendliche, Klinikum Nürnberg Süd
Outcome results
None listed