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Recruiting NCT05908227

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Trial Parameters

Condition Respiratory Distress Syndrome
Sponsor Insel Gruppe AG, University Hospital Bern
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 23 Weeks
Max Age 31 Weeks
Start Date 2023-07-01
Completion 2025-12
Interventions
NHF highNHF lowNCPAP

Brief 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 Criteria

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

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