P22.0
Conditions
Interventions
Group 1: The study comprises three study phases, each lasting 24 hours on three consecutive days. During the first study phase, the children receive either CPAP or CPAP-Backup ventilation with automat
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. Preterm infants with a gestational age 20 seconds duration) and/or bradycardias (heart rate <100/min) in the 12 hours preceding study enrollment. 5. In the 12 hours preceding study enrollment, the number of provoked/intervention-requiring events (defined as SpO2 < 70% or heart rate <100/min) did not lead to escalation of non-invasive ventilation. 6. Written consent from the legal guardians has been 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 <120 hours (often acute deterioration in the early phase of respiratory distress syndrome and to adhere to the minimal-handling principle during the critical phase to prevent intraventricular hemorrhage). 3. Initiation of treatment for an acute clinical infection <72 hours before study enrollment. 4. Escalation of non-invasive ventilation in the 12 hours preceding study enrollment due to the number of provoked/intervention-requiring events (defined as SpO2 <70% or heart rate <100/min). 5. Planned blood transfusion or surgery during the study phase. 6. Study initiation <48 hours after immunization. 7. Retinopathy of prematurity (ROP) examination on study days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of pulse oximetry-measured oxygen saturation (SpO2) in 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 of each child during each study period. - Area under the curve above and below the individual SctO2 median of 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, after approximately 12 hours for child care, and at the end of the study after 24 hours) per study period. - Abdominal circumference measurement at the beginning and end of each study period. - Number of children meeting predefined termination criteria at any time and in any study phase | — |
Countries
Germany
Contacts
Public ContactAntje Westhoff
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Studienzentrale
Outcome results
None listed