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

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)

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.

This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.

Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.

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