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

Ain Shams University

Status: Enrolling

Conditions: Infant, Premature, Diseases; Infant, Newborn, Disease; Respiratory Tract Diseases; RDS

Treatments: Device: noninvasive high frequency oscillatory ventilation; Device: noninvasive positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05493527

MD 90/2020

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 minute to 1 month old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

noninvasive high frequency oscillatory ventilation (NHFOV)

Experimental group

Description:

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support

Treatment:

Device: noninvasive high frequency oscillatory ventilation

noninvasive positive pressure ventilation (NIPPV)

Active Comparator group

Description:

After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support

Treatment:

Device: noninvasive positive pressure ventilation