Clinical trial NCT05493527: Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates
Official title: Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Premature, Diseases
Infant, Newborn, Disease
Respiratory Tract Diseases
RDS
Keywords: noninvasive high frequency ventilation
noninvasive ventilation
RDS
post-extubation
preterm
respiratory distress syndrome
noninvasive positive pressure ventilation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Re-intubation rate
timeFrame: 72 hours
Secondary outcomes:
measure: Days on the assigned non-invasive respiratory support
timeFrame: 8 weeks or till patient discharge which comes first
measure: Days on supplemental oxygen
timeFrame: 8 weeks or till patient discharge which comes first
measure: Duration of admission
timeFrame: 8 weeks or till patient discharge which comes first
measure: Mortality rate
timeFrame: 8 weeks or till patient death which comes first
measure: Lung ultrasound score
timeFrame: Before extubation and after 2 hours on assigned mode
measure: Co2 change
timeFrame: Before extubation and after 2 hours on assigned mode
measure: Oxygen requirement
timeFrame: Before extubation and after 2 hours on assigned mode
measure: Incidence of feeding intolerance
timeFrame: 8 weeks or till patient weaning from assigned mode which comes first
measure: Days to reach full intake
timeFrame: 8 weeks or till patient discharge which comes first
measure: Intracranial hemorrhage
timeFrame: 8 weeks or till patient weaning from assigned mode which comes first
measure: Pneumothorax
timeFrame: 8 weeks or till patient weaning from assigned mode which comes first
measure: Incidence of occurrence of Nasal trauma
timeFrame: 8 weeks or till patient weaning from assigned mode which comes first
measure: incidence of bronchopulmonary dysplasia
timeFrame: 8 weeks or till patient discharge which comes first
measure: Severity of respiratory distress
timeFrame: Before extubation and and after 2 hours on assigned mode
measure: Need for Postnatal Steroids
timeFrame: 8 weeks or till patient discharge which comes first
measure: Chest x ray change
timeFrame: Before extubation and and after 2 hours on assigned mode
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Neonatal Intensive Care Units (NICUs), Ain Shams University
state: Abbasia
Study officials:
References: