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

Not Applicable

Completed

• Conditions: Noninvasive Ventilation; High-Frequency Ventilation; Newborn Morbidity; Intermittent Positive-Pressure Ventilation
• Interventions: Device: Non-invasive ventilation

• Registration Number: NCT04323397
• Lead Sponsor: Prince of Songkla University

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 Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Study Start: 2020-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-01
• Results First Submitted: 2023-09-10
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Results First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nasal high frequency oscillatory ventilation	Non-invasive ventilation	nHFO: flow 8-10 L/minute, frequency 10 Hz, MAP = "MAP (before extubation) + 2" or "8 (preterm), 10 (term)" cmH2O, dP = "2-3 times of MAP with visible chest oscillations" or 25-35 cmH2O, I:E = 1:1, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%
nasal synchronized intermittent positive pressure ventilation	Non-invasive ventilation	nSIPPV: flow 8-10 L/minute, rate 60/minute, PIP = "PIP (before extubation) + 2-5" or "20 (preterm), 25 (term)" cmH2O, PEEP = 5 cmH2O, IT = 0.5 s, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%. The highest trigger sensitivity avoiding auto triggering was selected.

Primary Outcome Measures

Name	Time	Method
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study	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 Outcome Measures

Name	Time	Method
Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.	up to 7 days after each intervention	Data from the Parallel Phase of the study: The participant with and without arterial line was randomized. If The participant with arterial line was randomized to cross-over trial (randomized to NIV, then switched to another NIV for 2 hours, then switched to the first NIV \[parallel trial\]). If The participant without arterial line was randomized to parallel trial. Extubation failure will be defined by reintubation after NIV mode.

Trial Locations

Locations (1)

Songklanagarind Hospital, Prince of Songkla University; 🇹🇭 Hat-Yai, Songkhla, Thailand