Clinical trial NCT04323397: Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study
Official title: Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-Frequency Ventilation
Intermittent Positive-Pressure Ventilation
Newborn Morbidity
Noninvasive Ventilation
Keywords: Nasal High-Frequency Oscillation
Nasal Synchronized Intermittent Positive Pressure
Respiratory Failure
Extubation Failure
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 133
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Controlled Crossover Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study
timeFrame: 2 hours after each intervention
Secondary outcomes:
measure: Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.
timeFrame: up to 7 days after each intervention
Other outcomes:
Locations:
city: Hat-Yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Anucha Thatrimontrichai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baingam K, Phatigomet M, Thatrimontrichai A, Maneenil G, Dissaneevate S, Janjindamai W. Carbon Dioxide Level between Nasal High-Frequency Oscillatory Ventilation and Synchronized Nasal Intermittent Positive Pressure Ventilation after Extubation in Neonates: A Cross-over Randomized Controlled Trial. Am J Perinatol. 2024 Aug;41(11):1495-1503. doi: 10.1055/a-2113-3284. Epub 2023 Jun 20.
citation: Phatigomet M, Thatrimontrichai A, Maneenil G, Dissaneevate S, Janjindamai W. Reintubation Rate between Nasal High-Frequency Oscillatory Ventilation versus Synchronized Nasal Intermittent Positive Pressure Ventilation in Neonates: A Parallel Randomized Controlled Trial. Am J Perinatol. 2024 Aug;41(11):1504-1511. doi: 10.1055/a-2118-5351. Epub 2023 Jun 27.
citation: Baingam K, Phatigomet M, Thatrimontrichai A, Maneenil G, Dissaneevate S, Janjindamai W. Erratum: Carbon Dioxide Level between Nasal High-Frequency Oscillatory Ventilation and Synchronized Nasal Intermittent Positive Pressure Ventilation after Extubation in Neonates: A Cross-over Randomized Controlled Trial. Am J Perinatol. 2024 Aug;41(11):e1. doi: 10.1055/s-0044-1778715. Epub 2024 Jan 24. No abstract available.
citation: Phatigomet M, Thatrimontrichai A, Maneenil G, Dissaneevate S, Janjindamai W. Erratum: Reintubation Rate between Nasal High-Frequency Oscillatory Ventilation versus Synchronized Nasal Intermittent Positive Pressure Ventilation in Neonates: A Parallel Randomized Controlled Trial. Am J Perinatol. 2024 Aug;41(11):e2. doi: 10.1055/s-0044-1778714. Epub 2024 Jan 24. No abstract available.