Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study — nHFOnSIPPV  

Noninvasive Ventilation Clinical Trial

Official title: Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study

Status Completed

Clinical Trial Summary

Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 [pCO2]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive.

Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6).

The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.

Clinical Trial Description

The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT. ;

Related Conditions & MeSH terms

• High-Frequency Ventilation
• Intermittent Positive-Pressure Ventilation
• Newborn Morbidity
• Noninvasive Ventilation

• NCT number: NCT04323397
• Study type: Interventional
• Source: Prince of Songkla University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Completion date: August 1, 2022