Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial

A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Disease; RDS
• Intervention / Treatment: Device: noninvasive high frequency oscillatory ventilation; Device: noninvasive positive pressure ventilation

Detailed Description

The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.

Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.

The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.

This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.

The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sondos Ahmed; Phone Number: 202 0109440704; Email: sondosahmedsalah@gmail.com

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11517
      • Recruiting
      • Neonatal Intensive Care Units (NICUs), Ain Shams University
      • Contact: Sondos Ahmed; Phone Number: 202 01094407204; Email: sondosahmed@med.asu.edu.eg
      • Contact: Email: sondosahmedsalah@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Preterm neonates with gestational age ≤ 35 weeks.
2. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation

Exclusion Criteria:

1. Patients with major upper or lower airway anomalies.
2. Patients with significant congenital anomalies including cardiac, abdominal or respiratory.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: noninvasive high frequency oscillatory ventilation (NHFOV); After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support	Device: noninvasive high frequency oscillatory ventilation; A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: a frequency of 10 Hertz ( range, 8-12 Hz);; an inspiratory time of 50% (1:1); an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space; Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy; fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.
Active Comparator: noninvasive positive pressure ventilation (NIPPV); After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support	Device: noninvasive positive pressure ventilation; NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: Peep ranging from 5 to 10 cmH2O,; Peak inspiratory pressure range 15-25 cmH2O; Rate range 40-50 breath/minute; FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intubation rate	Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days on the assigned non-invasive respiratory support	To document number of days on the assigned non-invasive respiratory support	8 weeks or till patient discharge which comes first
Days on supplemental oxygen	To document number of days on supplemental oxygen	8 weeks or till patient discharge which comes first
Duration of admission	To document total number of days of admission	8 weeks or till patient discharge which comes first
Mortality rate	To document incidence of mortality during hospitalization	8 weeks or till patient death which comes first
Lung ultrasound score	lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration.	Before extubation and after 2 hours on assigned mode
Co2 change	Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.	Before extubation and after 2 hours on assigned mode
Oxygen requirement	Fraction of inspired oxygen required to patients on assigned mode	Before extubation and after 2 hours on assigned mode
Incidence of feeding intolerance	Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode.	8 weeks or till patient weaning from assigned mode which comes first
Days to reach full intake	Number of days needed by each patient to reach full intake	8 weeks or till patient discharge which comes first
Intracranial hemorrhage	Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode.	8 weeks or till patient weaning from assigned mode which comes first
Pneumothorax	Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode.	8 weeks or till patient weaning from assigned mode which comes first
Incidence of occurrence of Nasal trauma	Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode.	8 weeks or till patient weaning from assigned mode which comes first
incidence of bronchopulmonary dysplasia	Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode.	8 weeks or till patient discharge which comes first
Severity of respiratory distress	Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing.	Before extubation and and after 2 hours on assigned mode
Need for Postnatal Steroids	Percentage of patients who needed postnatal steroids administration	8 weeks or till patient discharge which comes first
Chest x ray change	Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree.	Before extubation and and after 2 hours on assigned mode

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: preterm; noninvasive ventilation; RDS; respiratory distress syndrome; noninvasive high frequency ventilation; post-extubation; noninvasive positive pressure ventilation
• Additional Relevant MeSH Terms: Infant, Premature, Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases
• Other Study ID Numbers: MD 90/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No