P22.0
Conditions
Interventions
Group 1: Overall, three study phases, each lasting 24 hours. In this study phase (0-24h), nasal high-frequency oscillatory ventilation (nHFOV) is administered with airway pressure similar to that ach
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: 1. Premature infants with a gestational age 1min or heart rate 30 seconds) did not lead to an escalation of non-invasive ventilation. 6. Written consent of the legal guardians obtained.
Exclusion criteria
Exclusion criteria: 1. Preterm and newborn infants with severe malformations affecting respiratory regulation (severe CNS malformations), lung function (e.g., lung hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or cardiovascular function significantly (congenital cyanotic heart defects, severe septic shock). 2. Postnatal age 60% and/or PEEP >8cmH2O. 5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of irritated/intervention-requiring events (defined as SpO2 1min or heart rate 30 seconds). 6. Planned blood transfusion or surgery during the study phase. 7. Study initiation <48 hours after immunization. 8. ROP examination on study days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the absolute time, expressed as a percentage, of pulse oximetry-measured oxygen saturation (SpO2) within the oxygen saturation target range (88-96%). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number and duration of episodes with SpO2 96% 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 >60 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. • Mean transcutaneous pCO2 and standard deviation during each study period. • Assessment of the Silverman Score (clinical scoring system to determine the degree of respiratory distress) three times (every 12 hours) per study period. • Abdominal circumference measurement at the beginning and end of each study period. • Determination of spontaneous breathing at each care round (every 4-6 hours). • Number of children meeting predefined termination criteria at various time points and in different study phases. | — |
Countries
Germany
Contacts
Public ContactHarald Ehrhardt
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Outcome results
None listed