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

Not Applicable

• Conditions: Infant, Premature, Diseases; Infant, Newborn, Disease; Respiratory Tract Diseases; RDS
• Interventions: Device: noninvasive high frequency oscillatory ventilation; Device: noninvasive positive pressure ventilation

• Registration Number: NCT05493527
• Lead Sponsor: Ain Shams University

Brief Summary

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)

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 Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-07
• Last Update Submitted: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
noninvasive high frequency oscillatory ventilation (NHFOV)	noninvasive high frequency oscillatory ventilation	After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support
noninvasive positive pressure ventilation (NIPPV)	noninvasive positive pressure ventilation	After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Days on the assigned non-invasive respiratory support	8 weeks or till patient discharge which comes first	To document number of days on the assigned non-invasive respiratory support
Days on supplemental oxygen	8 weeks or till patient discharge which comes first	To document number of days on supplemental oxygen
Duration of admission	8 weeks or till patient discharge which comes first	To document total number of days of admission
Mortality rate	8 weeks or till patient death which comes first	To document incidence of mortality during hospitalization
Lung ultrasound score	Before extubation and after 2 hours on assigned mode	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.
Co2 change	Before extubation and after 2 hours on assigned mode	Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.
Oxygen requirement	Before extubation and after 2 hours on assigned mode	Fraction of inspired oxygen required to patients on assigned mode
Incidence of feeding intolerance	8 weeks or till patient weaning from assigned mode which comes first	Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode.
Days to reach full intake	8 weeks or till patient discharge which comes first	Number of days needed by each patient to reach full intake
Intracranial hemorrhage	8 weeks or till patient weaning from assigned mode which comes first	Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode.
Pneumothorax	8 weeks or till patient weaning from assigned mode which comes first	Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode.
Incidence of occurrence of Nasal trauma	8 weeks or till patient weaning from assigned mode which comes first	Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode.
incidence of bronchopulmonary dysplasia	8 weeks or till patient discharge which comes first	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.
Severity of respiratory distress	Before extubation and and after 2 hours on assigned mode	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.
Need for Postnatal Steroids	8 weeks or till patient discharge which comes first	Percentage of patients who needed postnatal steroids administration
Chest x ray change	Before extubation and and after 2 hours on assigned mode	Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree.

Trial Locations

Locations (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt