Influence of different settings of apnoea duration under CPAP backup ventilation in small preterm infants during weaning phase after respiratory distress syndrome - a prospective randomised clinical cross-over study

Not Applicable

Recruiting

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

• Registration Number: DRKS00031911
• 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: 2023-05-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

< 1500g birthweight and at least 120 old
- requirement for non-invasive ventilation (CPAP or CPAP backup).
- FiO2 on CPAP or CPAP backup 21% - 60% with a PEEP of 4-8 cmH20.
- at least 4 hypoxaemias (<80% SpO2) and/or apnoeas (>20 seconds
duration) and/or bradycardias (heart rate <100/min) in the 12 hours
before study entry
- in the 12 hours prior to study entry, the number of irritable/intervention
events (defined as SpO2 < 70% for > 1min or heart rate < 100/min for > 30
seconds) did not lead to escalation of non-invasive ventilation
- written consent of the legal guardian is given

Exclusion Criteria

- Premature and newborn infants with severe malformations that
significantly impair respiratory regulation (severe CNS malformations),
lung function (e.g. pulmonary hypoplasia, acute extra-alveolar air such as
pneumothorax and pulmonary interstitial emphysema, diaphragmatic
hernias) or circulatory function (congenital cyanotic cardiac vitals, severe
septic shock).
- Postnatal age <120 hours of life (often acute deterioration in the early
phase of respiratory distress syndrome and to protect the minimal-
handling principle in the critical phase to prevent intraventricular
haemorrhage)
- Initiation of treatment for an acute clinical infection < 72 hours prior to
study entry
- FiO2 on CPAP or CPAP backup >60% and/or PEEP > 8cmH20
- Escalation of non-invasive ventilation in the 12 hours prior to study entry
due to the number of irritable/intervention events (defined as SpO2 <
70% for > 1min or heart rate < 100/min for > 30 seconds)
- Planned blood transfusion or surgery during the study period
- Activated FiO2 controller on ventilator, as this will administer ventilator
breaths when SpO2 falls below the set saturation target range.

Study & Design

• Study Type: interventional
• Study Design: Not specified