Evaluating breathing support methods for preterm infants
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
NA · Insel Gruppe AG, University Hospital Bern · NCT05908227
This study is testing whether a new breathing support method called nasal high flow therapy can help stable preterm infants with breathing problems feel more comfortable compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 23 Weeks to 31 Weeks |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 2 sites (Mainz, Rhineland-Palatinate and 1 other locations) |
| Trial ID | NCT05908227 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants up to 31+6 weeks gestational age who are stable on NCPAP for at least 24 hours.
Not a fit: Patients with significant fetal anomalies or those requiring primary palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more comfortable and effective breathing support option for preterm infants.
How similar studies have performed: While NCPAP is the current gold standard, NHF is a promising alternative that has shown potential in other studies, though this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mainz, Rhineland-Palatinate and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Distress Syndrome, Nasal high flow therapy, Continuous positive airway pressure