Influence of high-flow nasal cannula versus O2 nasal cannula on parameters of oxygenation and ventilation in small preterm infants in weaning from respiratory support - a prospective randomised clinical trial

Not Applicable

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

• Registration Number: DRKS00031963
• 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: 2023-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Preterm infants with a gestational age <32 weeks of gestation and a birth
weight <1500g
- Requirement for non-invasive ventilation (CPAP or CPAP backup)
- FiO2 on CPAP or CPAP backup 21% - 60% at a PEEP of 4-8
cmH20
- At least 4 hypoxaemias (< 80% SpO2) and/or apnoeas (>20
seconds duration) and/or bradycardia (heart rate <100/min) in the
12 hours prior to 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 for > 1min or heart rate < 100/min for > 30 seconds) did not result in
an Escalation of non-invasive ventilation
- Written consent of the legal guardian has been obtained

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 acute clinical infection < 72 hours prior to study
entry
- FiO2 under 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 the 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

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the time of pulsoximetrically measured oxygen saturation (SpO2) in the oxygen saturation target range (88-95%) related to the total time (in percent).