Influence of Different Settings of End-Expiratory Pressure Levels in CPAP or CPAP-Backup Ventilation for Small Preterm Infants in the Weaning Phase After Respiratory Distress Syndrome – A Prospective Randomized Clinical Crossover Study

Not Applicable

Conditions: P22.0
Respiratory distress syndrome of newborn

Registration Number: DRKS00033822

Lead Sponsor: niversitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 24

Inclusion Criteria

• Preterm infants with a gestational age <32 weeks and a birth weight <1500g who are being treated in the neonatology section of the Intensive Care Unit at the University Hospital Ulm and are at least 120 hours old.
• Requirement for non-invasive ventilation (CPAP or CPAP backup)
• FiO2 under CPAP or CPAP backup 21% - 60% with a PEEP of 3-6 cmH20
• Minimum of 4 hypoxemic episodes (< 80% SpO2) and/or apneas (>20 seconds duration) and/or bradycardias (heart rate <100/min) in the 12 hours before study entry
• In the 12 hours before study entry, the number of irritated/intervention-required events (defined as SpO2 < 70% or heart rate < 100/min) did not lead to escalation of non-invasive ventilation
• Written consent from legal guardians has been obtained

Exclusion Criteria

• Premature and newborn infants with severe malformations affecting
respiratory regulation (severe CNS malformations), lung function (e.g.,
lung hypoplasia, acute extraalveolar air such as pneumothorax and
pulmonary interstitial emphysema, diaphragmatic hernias), or
cardiovascular function significantly (congenital cyanotic heart defects,
severe septic shock)
• Postnatal age <120 hours (frequent acute deterioration in the early phase
of respiratory distress syndrome and to adhere to the minimal-handling
principle in the critical phase for preventing intraventricular bleeding)
• Initiation of treatment for an acute clinical infection < 72 hours before
study entry
• FiO2 under CPAP or CPAP backup >60% and/or PEEP > 6cmH20
• Escalation of non-invasive ventilation in the 12 hours before study entry
due to the number of irritated/intervention-required events (defined as
SpO2 < 70% or heart rate < 100/min)
• Planned blood transfusion or surgery during the study phase
• Study initiation < 48 h after immunization
• ROP examination on study days

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the time of pulse oximetry-measured oxygen saturation (SpO2) within the oxygen saturation target range (88-95%) relative to the total time (in percentage).

Secondary Outcome Measures