Clinical trial NCT05908227: Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
Official title: Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Nasal high flow therapy
Continuous positive airway pressure
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Treatment failure
timeFrame: 24 hours
Secondary outcomes:
measure: Apneas and bradycardias
timeFrame: 24 hours
measure: Respiratory rate (RR)
timeFrame: 24 hours
measure: Heart rate (HR)
timeFrame: 24 hours
measure: Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)
timeFrame: 24 hours
measure: Frequency of any treatment failure
timeFrame: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.
measure: Rescue NCPAP
timeFrame: Individual study duration: estimated to be between 7 days to 10 weeks.
measure: Postmenstrual age (PMA) off positive pressure support
timeFrame: Estimated to be at a PMA of approximately 29 to 34 weeks.
measure: Postmenstrual age (PMA) off FiO2 > 0.21
timeFrame: Estimated to be at a PMA between approximately 28 to 34 weeks.
measure: Postmenstrual age (PMA) at discharge
timeFrame: Estimated to be at a PMA of approximately 38-40 weeks.
measure: Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention
timeFrame: 4 hours
measure: Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention
timeFrame: 4 hours
measure: Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention
timeFrame: 4 hours
measure: Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention
timeFrame: 4 hours
measure: Change in end-expiratory lung impedance (ΔEELI)
timeFrame: 48 hours
measure: Change in global inhomogeneity (ΔGI) index
timeFrame: 48 hours
measure: Change in variability of tidal volume (ΔTV)
timeFrame: 48 hours
measure: Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)
timeFrame: 48 hours
measure: Incidence of Bronchopulmonary dysplasia (BPD)
timeFrame: At 36 weeks PMA
measure: Urinary cortisol
timeFrame: 24 hours
measure: COMFORTneo score
timeFrame: 72 hours
measure: Revised Bernese Pain Scale for Neonates (BSN-R) score
timeFrame: 72 hours
measure: Parental assessment of comfort
timeFrame: 72 hours
measure: NASA Task Load Index (NASA-TLX)
timeFrame: 72 hours
measure: Nasal trauma score
timeFrame: Individual study duration: estimated to be between 7 days to 10 weeks.
measure: Behavioral Sleep stage classification for Preterm Infants (BeSSPI)
timeFrame: 24 hours
measure: Parental Bonding Questionnaire (PBQ)
timeFrame: At 36 weeks PMA
measure: Age at initiating breastfeeds
timeFrame: Estimated to be between 30-34 weeks PMA.
measure: Age at reaching full breastfeeds
timeFrame: Estimated to be between 34-40 weeks PMA.
measure: Weight
timeFrame: At 36 weeks PMA
measure: Head circumference
timeFrame: At 36 weeks PMA
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-University Mainz
state: Rheinland-Pfalz
city: Bern
country: Switzerland
facility: Department of Pediatrics, Inselspital
Study officials:
affiliation: Division of Neonatology, Department of Pediatrics, Inselspital
name: André Kidszun, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.