NCT04327466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

March 12, 2020

Last Update Submit

July 4, 2024

Conditions

Apnea of PrematurityInfant, Premature, Diseases

Keywords

Non-invasive respiratory supportNon-invasive high frequency oscillatory ventilationHighflow nasal cannula

Outcome Measures

Primary Outcomes (1)

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

    180-minute recording periods for each therapy

Secondary Outcomes (15)

  • Paired difference in respiratory rate

    180-minute recording periods for each therapy

  • Paired difference in heart rate

    180-minute recording periods for each therapy

  • Paired difference in fraction of inspired oxygen [FiO2]

    180-minute recording periods for each therapy

  • Paired difference in peripheral oxygen saturation [SpO2]

    180-minute recording periods for each therapy

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

    180-minute recording periods for each therapy

  • +10 more secondary outcomes

Study Arms (2)

Osciflow

EXPERIMENTAL

Crossover sequence of experimental treatment and active comparator.

Device: Osciflow

Highflow

ACTIVE COMPARATOR

Crossover sequence of experimental treatment and active comparator.

Device: Highflow

Interventions

OsciflowDEVICE

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).

Osciflow
HighflowDEVICE

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

Highflow

Eligibility Criteria

Age3 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe congenital malformations adversely affecting life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 31339005BACKGROUND

  • 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.

    PMID: 30549451BACKGROUND

MeSH Terms

Conditions

ApneaInfant, Premature, Diseases

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 31, 2020

Study Start

May 22, 2020

Primary Completion

November 26, 2021

Study Completion

November 26, 2021

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)