P22.0
Conditions
Interventions
Group 1: 2 study phases, each lasting 24 hours on two consecutive days. The first study phase takes place under Highflow therapy, in the second study period Highflow therapy takes place again on the f
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 bradycardia (heart rate 1min or heart rate for > 1min or heart rate 30 seconds) did not result in an Escalation of non-invasive ventilation - Written consent of the legal guardian has been obtained
Exclusion criteria
Exclusion criteria: - premature and newborn infants with severe malformations that significantly impair respiratory regulation (severe CNS malformations), lung function (e.g. pulmonary hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or circulatory function (congenital cyanotic cardiac vitals, severe septic shock) - postnatal age 60% and/or PEEP > 8cmH20 - escalation of non-invasive ventilation in the 12 hours prior to study entry due to the number of irritable/intervention events (defined as SpO2 1min or heart rate 30 seconds) - planned blood transfusion or surgery during the study period - activated FiO2 controller on the ventilator, as this will administer ventilator breaths when SpO2 falls below the set saturation target range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time of pulsoximetrically measured oxygen saturation (SpO2) in the oxygen saturation target range (88-95%) related to the total time (in percent). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and duration of episodes with SpO2 95% with oxygen demand during each study period - Number of long and very long hypoxic and hyperoxic episodes outside the target SpO2 range (defined as episodes lasting >30 seconds, >60 seconds, >120 seconds and >180 seconds) - Mean inspiratory air oxygen concentration (FiO2) during each study period - Median and mean SpO2 values and 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 each child's individual SctO2 median during each study period - SctO2 values <60, <55 and <50 - Mean transcutaneous pCO2 and standard deviation during each study period - Silverman score (clinical scoring system for determining the degree of respiratory distress) collected 3 times (every 4h, i.e. at the start of the study, after about 4h hours for the child's round of care and at the end of the study after 8h) per study period. - Abdominal circumference measurement at the beginning and at the end of each study period - Number of children who fulfil the predefined discontinuation criteria at which time and in which study period | — |
Countries
Germany
Contacts
Public ContactAntje Westhoff
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Outcome results
None listed