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

Not Applicable

Completed

• Conditions: Apnea of Prematurity; Infant, Premature, Diseases
• Interventions: Device: Highflow; Device: Osciflow

• Registration Number: NCT04327466
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-31
• Study Start: 2020-05-22
• Primary Completion: 2021-11-26
• Study Completion: 2021-11-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Highflow	Highflow	Crossover sequence of experimental treatment and active comparator.
Osciflow	Osciflow	Crossover sequence of experimental treatment and active comparator.

Primary Outcome Measures

Name	Time	Method
Paired difference in the total number of desaturations and bradycardia between Osciflow and HF	180-minute recording periods for each therapy

Secondary Outcome Measures

Name	Time	Method
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
Paired difference in the proportion of time spent with heart rates < 80 bpm	180-minute recording periods for each therapy
Paired difference in the number of apneas requiring stimulation	180-minute recording periods for each therapy
Paired difference in regional ventilation distribution in a subset of patients.	At the end of each intervention period	Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).
Paired difference in Tidal volumes in a subset of patients.	At the end of each intervention period	Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
Paired difference in nasal trauma score	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.
Paired difference in transcutaneous CO2 measurements	180-minute recording periods for each therapy
Paired difference in end-expiratory lung impedance (EELI) in a subset of patients.	At the end of each intervention period	EELI using electrical impedance tomography (arbitrary units per kilogram).
Paired difference in pain assessment using 'Bernese pain scale'	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.
Paired difference in the rate of pneumothorax	180-minute recording periods for each therapy
Paired difference in reaching 'failure criteria' to stop Osciflow or HF therapy:	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

Trial Locations

Locations (1)

Department of Neonatology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland