Evaluating breathing support methods for preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of nasal high flow therapy (NHF) compared to traditional nasal continuous positive airway pressure (NCPAP) in stable preterm infants with respiratory distress syndrome. The study is a multi-center, parallel group, three-arm randomized controlled trial that aims to assess cardiorespiratory stability and comfort levels in infants receiving different flow rates of NHF versus NCPAP. By determining whether NHF can provide similar benefits with improved comfort, the trial seeks to inform clinical practices for respiratory support in preterm infants.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Center of the Johannes Gutenberg-University Mainz
  Mainz, Rhineland-Palatinate, Germany Recruiting
• Department of Pediatrics, Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: André Kidszun, Prof. Dr. med. — Division of Neonatology, Department of Pediatrics, Inselspital
• Study coordinator: Lisa Marie Bünte
• Email: lisamarie.buente@insel.ch
• Phone: +41 31 632 19 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.