P22.0
Conditions
Interventions
Group 1: Non-invasive positive pressure ventilation
Group 2: Nasal high-frequency oscillatory ventilation
Sponsors
Menschen für Kinder e.V.
Eligibility
Sex/Gender
All
Age
3 Days to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Premature babies with a gestational age 1min or heart rate 30 seconds) does not lead to an escalation of the non-invasive ventilation. 6. Written consent of the legal guardian is given.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Premature babies and newborns 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 the circulatory function (congenital cyanotic heart disease, septic shock). 2. Postnatal age 60% and / or PEEP> 8cmH20. 5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of intervention-requiring events (defined as SpO2 1 min. or Heart rate 30 seconds). 6. Planned blood transfusion or surgery during the study phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the absolute time as a percentage of oxygen saturation (SpO2) measured by pulse oximetry in the target oxygen saturation range (88-96%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and duration of episodes with SpO2 96% with oxygen demand 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 inspiratory 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 below the curve above and below the individual SctO2 median of each child during each study period • Mean transcutaneous pCO2 and standard deviation during each study period • Collection of the Silverman score at the beginning, after 4 hours, and at the end of each study period • Measurement of the waist circumference at the beginning and at the end of each study period • Number of children who meet the pre-defined drop-out criteria at which point in time and in which phase of study • Non-invasive measurement of regional lung ventilation using electronic impedance tomography (EIT) | — |
Countries
Germany
Contacts
Public ContactHarald Ehrhardt
Universitätsklinikum Giessen und Marburg, Standort Giessen
Outcome results
None listed