About this trial
Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
>2nd day of life (defined as date day)
≤ 2 apneas with concomitant bradycardias (<100/min) per hour for the previous 6 hours
FiO2 ≤ 0.3 and not increasing
Disqualifiers
Significant fetal anomalies
Primary palliative care
Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
Trial design
Parallel
Treatments tested in this trial
NHF high
Other interventionNasal high flow therapy 8L/min.
NHF low
Other interventionNasal high flow therapy 6L/min.
NCPAP
Other interventionNasal continuous positive airway pressure 6 cm H20
Treatment groups
Trial outcomes
Primary outcomes
Treatment failure
Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention: 1. \>2 apneas with concomitant bradycardias (\<100/min) per hour for \> 1 hour or 2. FiO2 \> 0.3 consistently for \> 1 hour or 3. Significant chest recessions (Silverman Score ≥ 5) for \> 1 hour or 4. Respiratory rate \> 60/min consistently for \> 1 hour or 5. Any need for intermittent positive pressure ventilation The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).
Secondary outcomes
Apneas and bradycardias
The total frequency of apneas and bradycardias (\<100/min) within 24 hours of starting of intervention will be documented.
Respiratory rate (RR)
The mean RR within 24 hours of starting of intervention will be documented.
Heart rate (HR)
The mean HR within 24 hours of starting of intervention will be documented.
Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)
The mean SpO2/FiO2 ratio within 24 hours of starting of intervention will be documented.
Sponsors and contacts
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