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

January 12, 2022 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Department of Neonatology, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osciflow
Crossover sequence of experimental treatment and active comparator.
Device: Osciflow
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).
Active Comparator: Highflow
Crossover sequence of experimental treatment and active comparator.
Device: Highflow
Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paired difference in respiratory rate
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in heart rate
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in fraction of inspired oxygen [FiO2]
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in peripheral oxygen saturation [SpO2]
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in the proportion of time spent with oxygen saturations < 80%
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in the proportion of time spent with heart rates < 80 bpm
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in the number of apneas requiring stimulation
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
Paired difference in transcutaneous CO2 measurements
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
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.
180-minute recording periods for each therapy
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).
At the end of each intervention period
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).
At the end of each intervention period
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).
At the end of each intervention period
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.
At the end of each intervention period
Paired difference in the rate of pneumothorax
Time Frame: 180-minute recording periods for each therapy
180-minute recording periods for each therapy
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
180-minute recording periods for each therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

November 26, 2021

Study Completion (Actual)

November 26, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High frequency highflow

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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