Influence of Variation in Airway Pressure and Oscillation Frequency during High-Frequency Oscillatory Ventilation on Oxygenation and Ventilation Parameters in Preterm Infants in the Weaning Phase after Respiratory Distress Syndrome – A Randomized Clinical Study

Not Applicable

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

• Registration Number: DRKS00033816
• 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. Premature infants with a gestational age <32 weeks and a birth weight <1500g, treated at the neonatology intensive care unit of Ulm University Hospital, and at least 120 hours old.
2. Requirement for non-invasive ventilation (sNIPPV or nCPAP ± Backup).
3. FiO2 under CPAP-Backup/NIPPV 21% - 60% with a PEEP of 4-8 cmH2O.
4. At least 4 episodes of hypoxemia (<80% SpO2) and/or apnea/bradycardia in the 12 hours before study entry.
5. In the 12 hours before study entry, the number of irritated/intervention-requiring events (defined as SpO2 <70% for >1min or heart rate <100/min for >30 seconds) did not lead to an escalation of non-invasive ventilation.
6. Written consent of the legal guardians 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 protect the minimal-handling principle in the critical phase for the prevention of intraventricular bleeding).
3. Onset of treatment for an acute clinical infection <72 hours before study entry.
4.FiO2 under CPAP/NIPPV >60% and/or PEEP >8cmH2O.
5. Escalation of non-invasive ventilation in the 12 hours before study entry due to the number of irritated/intervention-requiring events (defined as SpO2 <70% for >1min or heart rate <100/min for >30 seconds).
6. Planned blood transfusion or surgery during the study phase.
7. Study initiation <48 hours after immunization.
8. 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 absolute time, expressed as a percentage, of pulse oximetry-measured oxygen saturation (SpO2) within the oxygen saturation target range (88-96%).