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

Recruiting now · Not applicable

Conditions studied: Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID: NCT05908227
Run by: Insel Gruppe AG, University Hospital Bern
People needed: 150
Starts: 2023-07-01
Expected to finish: 2026-02-01
Last updated by the study team: 2025-02-21

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

University Medical Center of the Johannes Gutenberg-University Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
Department of Pediatrics, Inselspital — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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