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

RecruitingNAAges 23 Weeks - 31 WeeksAllInsel Gruppe AG, University Hospital Bern
NCT05908227 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • NHF high
  • NHF low
  • NCPAP
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Where

2 sites
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Germany
Department of Pediatrics, Inselspital
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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