Clinical trial NCT04327466: Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
Official title: Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Infant, Premature, Diseases
Keywords: Non-invasive respiratory support
Non-invasive high frequency oscillatory ventilation
Highflow nasal cannula
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
timeFrame: 180-minute recording periods for each therapy
Secondary outcomes:
measure: Paired difference in respiratory rate
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in heart rate
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in fraction of inspired oxygen [FiO2]
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in peripheral oxygen saturation [SpO2]
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in the proportion of time spent with oxygen saturations < 80%
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in the proportion of time spent with heart rates < 80 bpm
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in the number of apneas requiring stimulation
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in transcutaneous CO2 measurements
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in pain assessment using 'Bernese pain scale'
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.
timeFrame: At the end of each intervention period
measure: Paired difference in regional ventilation distribution in a subset of patients.
timeFrame: At the end of each intervention period
measure: Paired difference in Tidal volumes in a subset of patients.
timeFrame: At the end of each intervention period
measure: Paired difference in nasal trauma score
timeFrame: At the end of each intervention period
measure: Paired difference in the rate of pneumothorax
timeFrame: 180-minute recording periods for each therapy
measure: Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:
timeFrame: 180-minute recording periods for each therapy
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Neonatology, University Hospital Zurich
Study officials:
References:
citation: Rub DM, Sivieri EM, Abbasi S, Eichenwald E. Effect of high-frequency oscillation on pressure delivered by high flow nasal cannula in a premature infant lung model. Pediatr Pulmonol. 2019 Nov;54(11):1860-1865. doi: 10.1002/ppul.24459. Epub 2019 Jul 24.
citation: Sivieri EM, Eichenwald E, Bakri SM, Abbasi S. Effect of high frequency oscillatory high flow nasal cannula on carbon dioxide clearance in a premature infant lung model: A bench study. Pediatr Pulmonol. 2019 Apr;54(4):436-443. doi: 10.1002/ppul.24216. Epub 2018 Dec 14.