P22.0
Conditions
Interventions
Group 1: The crossover study comprises two study phases, each lasting 24 hours on two consecutive days. The first study phase takes place after randomization under CPAP backup ventilation with an apne
Sponsors
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Eligibility
Sex/Gender
All
Age
5 Days to No maximum
Inclusion criteria
Inclusion criteria: - 20 seconds duration) and/or bradycardias (heart rate 1min or heart rate 30 seconds) did not lead to escalation of non-invasive ventilation - written consent of the legal guardian is given
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 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 percentage of time during which the pulse oximetrically measured oxygen saturation (SpO2) remains within the target range of 88–95%. Prior to the start of the study, standard cardiorespiratory monitoring – consisting of preductal pulse oximetry (General Electric Monitor Carescape B450, 8-second averaging), postductal pulse oximetry (Masimo Radical 7®, 2-second averaging), ECG, and respiratory rate – is extended to include noninvasive near-infrared spectroscopy for cerebral tissue oxygenation (Masimo O3®) and transcutaneous CO2 monitoring (Radiometer®, TCM 4). Data collection begins with the first study phase, which lasts 24 hours. On the following day, at the same time, the switch to the alternative apnea duration takes place. Ventilation settings – including positive end-expiratory pressure (PEEP), peak inspiratory pressure (PIP), backup rate, backup duration, and inspiratory time – remain unchanged throughout both study phases. The initial settings for the first study phase are based on the ventilation parameters used immediately prior to the start of the study. During the 16 hours preceding the first study phase as well as the 16-hour interval between the two study phases, noninvasive ventilation is provided in CPAP backup mode with a 16-second apnea duration in order to eliminate carryover effects between the phases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and duration of episodes with SpO2 95% requiring supplemental oxygen 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 inspiratory oxygen concentration (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 infant during each study period Area under the curve above and below the individual SctO2 median for each infant during each study period SctO2 values below <60%, <55%, and <50% Mean transcutaneous pCO2 and standard deviation during each study period Assessment of the Silverman score (clinical scoring system for evaluating the degree of respiratory distress) three times per study period (at study start, after approximately 12 hours during routine care, and at the end of the 24-hour period) Abdominal circumference measurement at the beginning and end of each study period (1 cm above the umbilicus and before feeding) Number of infants who meet the predefined discontinuation criteria, including the time point and study phase in which criteria were fulfilled | — |
Countries
Germany
Contacts
Public ContactAntje Westhoff
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Studienzentrale
Outcome results
None listed