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NCT Number: NCT05908227

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

23 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Rhineland-Palatinate, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NHF high

Other

Nasal high flow therapy 8L/min.

NHF low

Other

Nasal high flow therapy 6L/min.

nCPAP

Other

Nasal continuous positive airway pressure 6 cm H20

Primary outcomes

  1. Treatment failure

    Time frame: 24 hours

    Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention:

    • >2 apneas with concomitant bradycardias (<100/min) per hour for > 1 hour or
    • FiO2 > 0.3 consistently for > 1 hour or
    • Significant chest recessions (Silverman Score ≥ 5) for > 1 hour or
    • Respiratory rate > 60/min consistently for > 1 hour or
    • Any need for intermittent positive pressure ventilation

    The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).

Secondary outcomes

  1. Apneas and bradycardias

    Time frame: 24 hours

    The total frequency of apneas and bradycardias (<100/min) within 24 hours of starting of intervention will be documented.

  2. Respiratory rate (RR)

    Time frame: 24 hours

    The mean RR within 24 hours of starting of intervention will be documented.

  3. Heart rate (HR)

    Time frame: 24 hours

    The mean HR within 24 hours of starting of intervention will be documented.

  4. Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)

    Time frame: 24 hours

    The mean SpO2/FiO2 ratio within 24 hours of starting of intervention will be documented.

  5. 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.

    Treatment failure is a composite outcome (see "Outcome 1"). The frequency of any treatment failure during the duration of the study will be documented.

  6. Rescue NCPAP

    Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.

    Rescue NCPAP is defined as NCPAP >6 cm H2O. The frequency of need for Rescue NCPAP during the duration of the study will be collected.

  7. Postmenstrual age (PMA) off positive pressure support

    Time frame: Estimated to be at a PMA of approximately 29 to 34 weeks.

    The investigators will document the PMA when the infant is off positive pressure support.

  8. Postmenstrual age (PMA) off FiO2 > 0.21

    Time frame: Estimated to be at a PMA between approximately 28 to 34 weeks.

    The investigators will document the PMA when the infant is off FiO2 > 0.21

  9. Postmenstrual age (PMA) at discharge

    Time frame: Estimated to be at a PMA of approximately 38-40 weeks.

    The investigators will document the PMA when the infant is being discharged from the hospital.

  10. Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention

    Time frame: 4 hours

    The cerebral oxygen saturation (cRSO2) in [%] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).

  11. Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention

    Time frame: 4 hours

    The time spent <55% cRSO2 in [min] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).

  12. Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention

    Time frame: 4 hours

    The cerebral oxygen saturation (cRSO2) in [%] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).

  13. Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention

    Time frame: 4 hours

    The time spent <55% cRSO2 in [min] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).

  14. Change in end-expiratory lung impedance (ΔEELI)

    Time frame: 48 hours

    The change Δ in end-expiratory lung impedance (ΔEELI) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.

    The measurements will take place:

    • within 30 minutes before starting of intervention (baseline measurement)
    • 3 minutes before until 3 minutes after starting of intervention
    • within 30 minutes after starting of intervention
    • 2, 6, 12, 24, 36, and 48 hours after starting of intervention

  15. Change in global inhomogeneity (ΔGI) index

    Time frame: 48 hours

    The change Δ in global inhomogeneity (ΔGI) index will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.

    The measurements will take place:

    • within 30 minutes before starting of intervention (baseline measurement)
    • 3 minutes before until 3 minutes after starting of intervention
    • within 30 minutes after starting of intervention
    • 2, 6, 12, 24, 36, and 48 hours after starting of intervention

  16. Change in variability of tidal volume (ΔTV)

    Time frame: 48 hours

    The change Δ in variability of tidal volume (ΔTV) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.

    The measurements will take place:

    • within 30 minutes before starting of intervention (baseline measurement)
    • 3 minutes before until 3 minutes after starting of intervention
    • within 30 minutes after starting of intervention
    • 2, 6, 12, 24, 36, and 48 hours after starting of intervention

  17. Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)

    Time frame: 48 hours

    The change Δ in ratio of tidal volume anterior/posterior (ΔRatio TV ap) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes.

    The measurements will take place:

    • within 30 minutes before starting of intervention (baseline measurement)
    • 3 minutes before until 3 minutes after starting of intervention
    • within 30 minutes after starting of intervention
    • 2, 6, 12, 24, 36, and 48 hours after starting of intervention

  18. Incidence of Bronchopulmonary dysplasia (BPD)

    Time frame: At 36 weeks PMA

    The incidence with specification of severity of BPD at 36 weeks PMA will be documented. BPD is a form of chronic lung disease (CLD).

    BPD is classified into 3 levels of severity according to the internationally used definition of Jobe and Bancalari (1).

    FiO2 >0.21 for ≥ 28 days and

    • Breathing room air (mild)
    • FiO2 <0.3 (moderate)
    • FiO2 ≥ 0.3 and/or positive pressure support (severe)

    (1) Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163(7):1723-9.

  19. Urinary cortisol

    Time frame: 24 hours

    A 24-hour-urine-sample will be collected on the third study day. The urinary production rates of cortisol and the most important metabolites will be documented as an indicator for infant stress.

  20. COMFORTneo score

    Time frame: 72 hours

    The COMFORTneo score will be documented on the third, fourth and fifth study day. The score measures comfort and chronic pain by observation.

  21. Revised Bernese Pain Scale for Neonates (BSN-R) score

    Time frame: 72 hours

    The BSN-R score will be documented on the third, fourth and fifth study day. The score measures pain.

  22. Parental assessment of comfort

    Time frame: 72 hours

    The parents will be asked 3 predefined questions concerning their infants' comfort on the on the third, fourth and fifth study day.

  23. NASA Task Load Index (NASA-TLX)

    Time frame: 72 hours

    The NASA-TLX will be filled out by the participants' nurses on the third, fourth and fifth study day. The NASA-TLX is a questionnaire that measures workload.

  24. Nasal trauma score

    Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.

    The nasal trauma score is assessed according to internal standard guidelines in case of a present nasal trauma. The highest respective score and time of assessment will be documented on the participant CRF at 36 weeks PMA. Measuring nasal trauma using the Nasal trauma score takes approximately 20 seconds.

  25. Behavioral Sleep stage classification for Preterm Infants (BeSSPI)

    Time frame: 24 hours

    Sleep-wake cycles as determined by the BeSSPI on the fourth study day will be documented. The BeSSPI identifies sleep stages by observation and takes approximately 2.5 hours.

  26. Parental Bonding Questionnaire (PBQ)

    Time frame: At 36 weeks PMA

    The score of the PBQ will be documented at 36 weeks PMA. The PBQ investigates infant-parental bonding.

  27. Age at initiating breastfeeds

    Time frame: Estimated to be between 30-34 weeks PMA.

    The postmenstrual age (PMA) at initiating breastfeeds will be documented. This refers to the PMA at which the first successful breastfeeding attempt takes place.

  28. Age at reaching full breastfeeds

    Time frame: Estimated to be between 34-40 weeks PMA.

    The postmenstrual age (PMA) at reaching full breastfeeds will be documented. This corresponds to 100% nutrition per breastfeeds for 24 consecutive hours.

  29. Weight

    Time frame: At 36 weeks PMA

    The weight in [g] at 36 weeks postmenstrual age (PMA) will be documented.

  30. Head circumference

    Time frame: At 36 weeks PMA

    The head circumference in [cm] at 36 weeks postmenstrual age (PMA) will be documented.

Study contacts

Contact information is provided by the study sponsor or research team.

André Kidszun, Prof. Dr. med.

CONTACT

[email protected]

+41 31 632 14 01

Lisa Marie Bünte

CONTACT

[email protected]

+41 31 632 19 23

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: MASTER

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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