Kurzfassung

Background: Nasal high flow therapy (NHF) is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional nasal continuous positive airway pressure (NCPAP), clinicians are likely to
adopt this method for widespread clinical use because of its improved comfort and potential
other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm
infants treated with...Background: Nasal high flow therapy (NHF) is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional nasal continuous positive airway pressure (NCPAP), clinicians are likely to
adopt this method for widespread clinical use because of its improved comfort and potential
other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm
infants treated with two commonly used nasal high flowrates in comparison to NCPAP.
Secondary aim is to examine potential comfort-related beneficial effects of NHF

Primary hypothesis:
Nasal high flow therapy 6 and 8 L/min are non-inferior to NCPAP 6 cm H2O in terms of
treatment failure within 24 hours of starting the intervention using a non-inferiority margin Δ
of 15%. Treatment failure is a composite endpoint of cardiorespiratory stability in preterm
infants composed of: frequency of apneas and concomitant bradycardias, supplemental
oxygen, work of breathing, respiratory rate and the need for intermittent positive pressure
ventilation.
Secondary and exploratory hypotheses:
1) There is no statistical difference between NHF 6, 8 L/min and NCPAP 6 cm H2O for
the secondary endpoints cardiorespiratory status, cerebral oxygenation and lung
aeration.
2) NHF 6 and 8 L/min are superior to NCPAP 6 cm H2O for the exploratory endpoints
comfort, pain, nasal trauma, sleep, bonding, feeding and workload» weiterlesen» einklappen