Influence of different settings of the FiO2 controller under CPAP±Backup ventilation in small preterm infants in the weaning phase after respiratory distress syndrome – a prospective randomized clinical cross-over study.

Not Applicable

• Conditions: P22.0; Respiratory distress syndrome of newborn

• Registration Number: DRKS00033767
• Lead Sponsor: niversitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin, Sektion Neonatologie und pädiatrische Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Preterm infants with a gestational age <32 weeks and birth weight <1500g, receiving treatment in the neonatology section of the intensive care unit at the University Hospital Ulm and aged at least 120 hours.
2. Requirement for non-invasive ventilation (CPAP or CPAP-Backup).
3.FiO2 under CPAP±Backup = 21%.
4. At least 4 episodes of hypoxemia (<80% SpO2) and/or apneas (>20 seconds duration) and/or bradycardias (heart rate <100/min) in the 12 hours preceding study enrollment.
5. In the 12 hours preceding study enrollment, the number of provoked/intervention-requiring events (defined as SpO2 < 70% or heart rate <100/min) did not lead to escalation of non-invasive ventilation.
6. Written consent from the legal guardians has been obtained.

Exclusion Criteria

1. Preterm and newborn infants with severe malformations affecting respiratory regulation (severe CNS malformations), lung function (e.g., lung hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or cardiovascular function significantly (congenital cyanotic heart defects, severe septic shock).
2. Postnatal age <120 hours (often acute deterioration in the early phase of respiratory distress syndrome and to adhere to the minimal-handling principle during the critical phase to prevent intraventricular hemorrhage).
3. Initiation of treatment for an acute clinical infection <72 hours before study enrollment.
4. Escalation of non-invasive ventilation in the 12 hours preceding study enrollment due to the number of provoked/intervention-requiring events (defined as SpO2 <70% or heart rate <100/min).
5. Planned blood transfusion or surgery during the study phase.
6. Study initiation <48 hours after immunization.
7. Retinopathy of prematurity (ROP) examination on study days.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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