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Recruiting NCT05908227

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

No phase Interventional Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NHF high, NHF low, NCPAP.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome. Basic parameters: 23 Weeks — 31 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Other NHF high
    Nasal high flow therapy 8L/min.
  • Other NHF low
    Nasal high flow therapy 6L/min.
  • Other NCPAP
    Nasal continuous positive airway pressure 6 cm H20

Primary outcome measures

  • Treatment failure [Time frame: 24 hours]
Secondary outcome measures (12)
  • Apneas and bradycardias [Time frame: 24 hours]
  • Respiratory rate (RR) [Time frame: 24 hours]
  • Heart rate (HR) [Time frame: 24 hours]
  • Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2) [Time frame: 24 hours]
  • Frequency of any treatment failure [Time frame: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.]
  • Rescue NCPAP [Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.]
  • Postmenstrual age (PMA) off positive pressure support [Time frame: Estimated to be at a PMA of approximately 29 to 34 weeks.]
  • Postmenstrual age (PMA) off FiO2 > 0.21 [Time frame: Estimated to be at a PMA between approximately 28 to 34 weeks.]
  • Postmenstrual age (PMA) at discharge [Time frame: Estimated to be at a PMA of approximately 38-40 weeks.]
  • Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention [Time frame: 4 hours]
  • Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention [Time frame: 4 hours]
  • Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention [Time frame: 4 hours]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Germany · 1 center
  • University Medical Center of the Johannes Gutenberg-University Mainz — Mainz
Switzerland · 1 center
  • Department of Pediatrics, Inselspital — Bern

Publications

  • Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. PMID 11401896

Identifiers

NCT: NCT05908227 · 2022-02287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗