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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Respiratory Distress Syndrome

Treatments: Other: NCPAP; Other: NHF high; Other: NHF low

Study type: Interventional

Funder types: Other

Identifiers

NCT05908227

2022-02287

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 23 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

NHF high

Experimental group

Description:

Nasal high flow therapy 8L/min

Treatment:

Other: NHF high

NHF low

Experimental group

Description:

Nasal high flow therapy 6L/min

Treatment:

Other: NHF low

NCPAP

Active Comparator group

Description:

Nasal continuous positive airway pressure 6 cm H20

Treatment:

Other: NCPAP