P22.0
Conditions
Interventions
Group 1: nSIMV - Nasal synchronized intermittent mechanical ventilation with fixed parameters:
Frequency: 40/min.
Inspiratory time (I-time): 0.3 seconds.
PEEP: Adjusted to match the mean airway pressu
Sponsors
Universistätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
5 Days to No maximum
Inclusion criteria
Inclusion criteria: - Preterm infants with a gestational age 20 seconds) and/or bradycardia (heart rate <100/min) within the 12 hours prior to study entry. - No escalation of non-invasive ventilation in the 12 hours prior to study entry due to events such as SpO2 <70% or heart rate <100/min. - Written informed consent from the legal guardians.
Exclusion criteria
Exclusion criteria: - Preterm and newborn infants with severe malformations significantly impairing respiratory regulation (e.g., severe CNS malformations), lung function (e.g., pulmonary hypoplasia, pneumothorax, diaphragmatic hernia), or circulatory function (e.g., congenital cyanotic heart defects, severe septic shock). - Postnatal age 60%. - Escalation of non-invasive ventilation in the 12 hours prior to study entry due to events (e.g., SpO2 <70% or heart rate <100/min). - Planned blood transfusion or surgery during the study period. Study start <48 hours after immunization. - ROP examination (Retinopathy of Prematurity) on study days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of pulse oximetry-measured oxygen saturation (SpO2) within the target range of 88-95%, expressed as a percentage of total time. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and duration of episodes with SpO2 95% - Average inspiratory oxygen concentration (FiO2) - Cerebral tissue oxygenation (SctO2) and related cerebral parameters - Variability of oxygen saturation and additional measures such as the Silverman score, abdominal | — |
Countries
Germany
Contacts
Public ContactAntje Westhoff
Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin
Outcome results
None listed