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Completed

NCT Number: NCT04327466

Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants

This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in premature infants. It uses a crossover design. Infants are randomized to begin the study with either Osciflow or HF. Both modes are applied for 4 hours. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate, and with a transcutaneous CO2-transducer. Further measurements include respiratory rate and 'Bernese pain scale' evaluated by nursing staff and Electrical Impedance Tomography (EIT) in a subset of patients.

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Key information

Conditions

Apnea of Prematurity Apnea Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

3 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neonatology, University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preterm infants born with a gestational age of <35 weeks
  • >72 hours old
  • On nCPAP with PEEP 5 mbar and FiO2 <0.3

Exclusion criteria

  • Severe congenital malformations adversely affecting life expectancy

Treatment and study plan

Osciflow

Device

Osciflow is a non-invasive high frequency oscillatory ventilation support delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Highflow

Device

Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

Primary outcomes

  1. Paired difference in the total number of desaturations and bradycardia between Osciflow and HF

    Time frame: 180-minute recording periods for each therapy

Secondary outcomes

  1. Paired difference in respiratory rate

    Time frame: 180-minute recording periods for each therapy

  2. Paired difference in heart rate

    Time frame: 180-minute recording periods for each therapy

  3. Paired difference in fraction of inspired oxygen [FiO2]

    Time frame: 180-minute recording periods for each therapy

  4. Paired difference in peripheral oxygen saturation [SpO2]

    Time frame: 180-minute recording periods for each therapy

  5. Paired difference in the proportion of time spent with oxygen saturations < 80%

    Time frame: 180-minute recording periods for each therapy

  6. Paired difference in the proportion of time spent with heart rates < 80 bpm

    Time frame: 180-minute recording periods for each therapy

  7. Paired difference in the number of apneas requiring stimulation

    Time frame: 180-minute recording periods for each therapy

  8. Paired difference in transcutaneous CO2 measurements

    Time frame: 180-minute recording periods for each therapy

  9. Paired difference in pain assessment using 'Bernese pain scale'

    Time frame: 180-minute recording periods for each therapy

    Bernese Pain-Scale for Neonates (BPSN): a 9-item multidimensional pain assessment tool that includes behavioral and physiological indicators. The instrument consists of seven subjective (alertness, crying, consolation, skin color, facial expression, posture, and changes in respiratory rate) and two physiological (i.e. objective) (changes in heart rate and oxygen saturation) indicators. Each item is rated on a four point Likert scale (0, 1, 2, and 3). Higher scores indicate greater pain-related distress, and a total score of 11 or higher is considered to indicate pain.

  10. Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.

    Time frame: At the end of each intervention period

    EELI using electrical impedance tomography (arbitrary units per kilogram).

  11. Paired difference in regional ventilation distribution in a subset of patients.

    Time frame: At the end of each intervention period

    Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).

  12. Paired difference in Tidal volumes in a subset of patients.

    Time frame: At the end of each intervention period

    Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).

  13. Paired difference in nasal trauma score

    Time frame: At the end of each intervention period

    Royal Women's Hospital Nasal Integrity and Pressure Chart.

    Nasal injury is defined as stage 0-skin intact; stage 1-nonblanchable erythema of intact skin; stage 2-partial thickness skin loss involving epidermis, dermis, or both; stage 3-full thickness skin loss involving damage to or necrosis of subcutaneous tissue; stage 4-full thickness skin loss with extensive destruction, tissue necrosis, or damage to supporting structures.

    Lowest Score: 0. Highest Score: 4. A higher score indicates more extensive nasal injury.

  14. Paired difference in the rate of pneumothorax

    Time frame: 180-minute recording periods for each therapy

  15. Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:

    Time frame: 180-minute recording periods for each therapy

    Definition of failure criteria

    • Respiratory rate >90/min for more than 30 minutes
    • Respiratory rate >20/min higher than at the beginning of the study
    • Increase in FiO2 by ≥ 0.25 from baseline for more than 30 minutes
    • Apnea-Score of more than 20/4 hours

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial

Acronym: Osciflow

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2020
Registry last updated
Jul 8, 2024

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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