P07.2
Conditions
Interventions
Group 1: The study is purely observational with no intervention or comparison groups. It examines the effects of routine clinical therapies (such as ventilation adjustments, oxygen therapy, and medica
Sponsors
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Preterm infants with a gestational age of 22+0/7 to 28+0/7 weeks. - Birth weight under 1500 grams. - Patients treated in the Neonatology and Pediatric Intensive Care Section of the University Hospital Ulm or at the Charite Berlin. - Requirement for invasive or non-invasive ventilation. - Written consent from legal guardians.
Exclusion criteria
Exclusion criteria: Preterm or newborn infants with severe malformations significantly affecting: - Respiratory regulation (e.g., severe central nervous system malformations), - Lung function (e.g., pulmonary hypoplasia, acute extra-alveolar air conditions such as pneumothorax or pulmonary interstitial emphysema), - Circulatory function (e.g., congenital cyanotic heart defects, severe septic shock). - Other severe conditions incompatible with the study’s objectives or safety requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the proportion of time spent within the center-specific target oxygen saturation range, measured by pulse oximetry (SpO2), before and after routine clinical interventions or clinical events. In general, the comparison is performed over a period of 6 hours before and 6 hours after the intervention or event. For blood transfusions, intubation, and sedation measures, an observation period of 24 hours before and after the event is considered. The aim is to assess whether clinical measures promote stability of oxygen saturation within the target range. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number, duration, and severity of oxygen saturation episodes below 88%, 80%, and 70%, as well as above 95% in the presence of oxygen requirement, before and after routine clinical interventions or clinical events. Number and duration of prolonged hypoxemic and hyperoxemic episodes outside the target SpO2 range, particularly episodes lasting >30 seconds, >60 seconds, >120 seconds, and >180 seconds. Mean inspired oxygen concentration (FiO2) before and after routine clinical interventions or clinical events. Mean and median SpO2 values as well as SpO2 variability, measured as coefficient of variation, before and after routine clinical interventions or clinical events. Number and type of clinical interventions per day of life. In cases of intubation, extubation, and sedation measures: change in the time spent within the target SpO2 range, as well as frequency, duration, and severity of hypoxemic and hyperoxemic episodes before and after the intervention. In cases of clinical events, e.g. nosocomial infection, aspiration, or hypo-/hyperthermia: change in the time spent within the target SpO2 range, hypoxemic and hyperoxemic episodes, and FiO2 before and after onset of the event. In selected patients: description or assessment of changes in lung ventilation using electrical impedance tomography (EIT) in relation to routine clinical measures. In selected patients: observational recording of breathing movements and breath sounds using Quietam Nox, as well as evaluation of contactless detection of respiratory events compared with clinical monitoring. | — |
Countries
Germany
Contacts
Public ContactStephanie Ströbele
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Outcome results
None listed