P28.4
Conditions
Interventions
Group 1: Phase I with a duration of 8h:
Use of CPAP breathing support in preterm infants
Group 2: Phase II with a duration of 8 h:
After randomization once again use of CPAP breathing support or appli
Sponsors
Universitätsklinikum Gießen, Abteilung Allgemeine Pädiatrie und Neonatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Premature infants (birth weight 2 irritable/intervention events/4h (defined as SpO2 1 min or heart rate 30 seconds) before study entry 6. Written informed consent from the legal guardians has been obtained
Exclusion criteria
Exclusion criteria: 1. Premature and newborn infants with severe malformations that significantly affect respiratory regulation (severe CNS malformations), pulmonary function (e.g. pulmonary hypoplasia, acute extraalveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or circulatory function (congenital cynaotic cardiac disease, severe septic shock) 2. Postnatal age 10 mg/l) with or without circulatory insufficiency or positive blood culture 4. FiO2 under CPAP/NIPPV > 0.3 with PEEP > 5 mmHg 5. Significant apnoea-bradycardia-syndrome (> 2 irritable/intervention events/4h = SpO2 1 min or heart rate 30 seconds) before study entry 6. Anticipatory blood transfusion during the study phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute time in percent (%) preterm infants spent within the specific oxygen saturation target range (88-95%). | — |
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 > 60 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 - Number of apnoea episodes lasting > 10 seconds during each study episode - Measurement of cerebral tissue oxygenation (SctO2) - Individual median SctO2 of each child during each study period - Area under the curve above and below each child's individual SctO2 median during each study period - Mean transcutaneous pCO2/paO2 and standard deviation during each study period - Determination of the Silverman score (clinical scoring system to determine the degree of respiratory distress) - Measurement of regional lung ventilation by electronic impedance tomography - Abdominal circumference measurement at the beginning and at the end of each study period - Number of children meeting the predefined discontinuation criteria at which time point and in which study period | — |
Countries
Germany
Contacts
Public ContactRahel Schuler
Universitätsklinikum Gießen, Abteilung Allgemeine Pädiatrie und Neonatologie
Outcome results
None listed