NCPAP: Nasal continuous positive airway pressure 6 cm H20
Study summary
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
Sex
ALL
Min age
23 Weeks
Max age
31 Weeks
Healthy volunteers
No
Inclusion Criteria:
Inclusion if all apply.
* 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)
* Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:
* ≤ 2 apneas with concomitant bradycardias (\<100/min) per hour for the previous 6 hours
* FiO2 ≤ 0.3 and not increasing
* No significant chest recessions (Silverman Score \< 5)
* Respiratory rate ≤ 60/min
* No need for intermittent positive pressure ventilation
* Parents with an age 18+ years
* Written parental informed consent (or other legal representative)
Exclusion Criteria:
Exclusion if any applies.
* Significant fetal anomalies
* Primary palliative care
* Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
Primary outcome measure(s)
Treatment failure — 24 hours 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).
Trial sites (2)
Facility
City
Region
Status
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz
Rhineland-Palatinate
Recruiting
Department of Pediatrics, Inselspital
Bern
Switzerland
Recruiting
More Insel Gruppe AG, University Hospital Bern trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.