Actively Recruiting
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-02-21
150
Participants Needed
2
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants up to 31 weeks and 6 days gestational age admitted to the specified neonatal units in Switzerland or Germany
- Older than 2 days of life
- Stable on NCPAP 6 cm H2O for at least 24 hours with no more than 2 apneas with bradycardia per hour in the last 6 hours
- Oxygen need (FiO2) 0.3 or less and not increasing
- No significant chest recessions (Silverman Score less than 5)
- Respiratory rate 60 breaths per minute or less
- No need for intermittent positive pressure ventilation
- Parents aged 18 years or older
- Written parental informed consent obtained
You will not qualify if you...
- Significant fetal anomalies
- Receiving primary palliative care
- Stable on NCPAP 6 cm H2O for more than 120 hours according to stability criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
2
Department of Pediatrics, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
L
Lisa Marie Bünte
CONTACT
A
André Kidszun, Prof. Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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