P22.0
Conditions
Interventions
Group 1: The study comprises 2 study phases, each lasting 24 hours on consecutive days. In one study phase, the PEEP remains the same as the PEEP before randomization. All children undergo both study
Sponsors
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Eligibility
Sex/Gender
All
Age
5 Days to 32 Weeks
Inclusion criteria
Inclusion criteria: • Preterm infants with a gestational age 20 seconds duration) and/or bradycardias (heart rate <100/min) in the 12 hours before study entry • In the 12 hours before study entry, the number of irritated/intervention-required events (defined as SpO2 < 70% or heart rate < 100/min) did not lead to escalation of non-invasive ventilation • Written consent from legal guardians has been obtained
Exclusion criteria
Exclusion criteria: • Premature and newborn infants with severe malformations affecting respiratory regulation (severe CNS malformations), lung function (e.g., lung hypoplasia, acute extraalveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or cardiovascular function significantly (congenital cyanotic heart defects, severe septic shock) • Postnatal age 60% and/or PEEP > 6cmH20 • Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of irritated/intervention-required events (defined as SpO2 < 70% or heart rate < 100/min) • Planned blood transfusion or surgery during the study phase • Study initiation < 48 h after immunization • ROP examination on study days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time of pulse oximetry-measured oxygen saturation (SpO2) within the oxygen saturation target range (88-95%) relative to the total time (in percentage). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number and duration of episodes with SpO2 95% with oxygen requirement during each study period. • Number of long and very long hypoxic and hyperoxic episodes outside the SpO2 target range (defined as episodes lasting >30 seconds, >60 seconds, >120 seconds, and >180 seconds). • Mean oxygen concentration in the inspired air (FiO2) during each study period. • Median and mean SpO2 values, as well as SpO2 variability (coefficient of variation), during each study period. • Measurement of cerebral tissue oxygenation (SctO2). - Individual SctO2 median for each child during each study period. - Area under the curve above and below the individual SctO2 median for each child during each study period. - SctO2 values <60, <55, and <50. • Mean transcutaneous pCO2 and standard deviation during each study period. • Assessment of the Silverman Score (clinical scoring system for determining the degree of respiratory distress) 3 times (every 12 hours, i.e., study start, approximately 12 hours for the child's care round, and at the end of the 24- hour study) per study period. • Abdominal circumference measurement at the beginning and end of each study period. • Number of children meeting predefined discontinuation criteria, indicating when and in which study phase these criteria are met. | — |
Countries
Germany
Contacts
Public ContactAntje Westhoff
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Studienzentrale
Outcome results
None listed