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Clinical Trials/NCT04323397
NCT04323397CompletedNot Applicable

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

Prince of Songkla University2 sites in 1 country133 target enrollmentStarted: July 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
133
Locations
2
Primary Endpoint
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study

Study Overview

Brief 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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Day to 1 Month (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Born in hospital and admit in NICU
  • The first endotracheal intubation and need NIV if extubation
  • Umbilical arterial catheterization to draw the blood gas
  • Neonate has not been intervened from another RCT study

Exclusion Criteria

  • Major congenital anomalies or chromosomal abnormalities
  • Neuromuscular diseases
  • Upper respiratory tract abnormalities
  • Suspected congenital lung diseases or pulmonary hypoplasia
  • Need for surgery known before the first extubation
  • Grade IV intraventricular hemorrhage occurring before the first extubation
  • Palliative care
  • Parents' decision not to participate

Outcomes

Primary Outcomes

Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study

Time Frame: 2 hours after each intervention

Data from the Crossover Phase of the study: After randomization only in neonate with arterial line, the initial non-invasive ventilation (NIV) was started then blood gas was obtained after 2 hours. The participant was switched to another NIV and blood gas was obtained after 2 hours.

Secondary Outcomes

  • Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.(up to 7 days after each intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anucha Thatrimontrichai

Principal Investigator

Prince of Songkla University

Study Sites (2)

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