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N/A N=102 Randomized Treatment

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

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

Enrolled (actual)
102
Serious AEs
3.0%
Results posted
Mar 2025
Primary outcome: Primary: Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study — 38.7; 36.8 mm Hg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Non-invasive ventilation (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Prince of Songkla University
Primary completion
Jun 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study
38.7; 36.8
SECONDARY
Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.
5; 4

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04323397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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