High-Frequency VentilationnHFOnSIPPVNCT04323397
Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study
A study testing Non-invasive ventilation in people with High-Frequency Ventilation and Intermittent Positive-Pressure Ventilation, run by Prince of Songkla University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation, Newborn Morbidity
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study
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.
Read the detailed description
The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.
- Conditions
- High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation, Newborn Morbidity, Noninvasive Ventilation
- Being tested
- Non-invasive ventilation
- Keywords
- Nasal High-Frequency Oscillation, Nasal Synchronized Intermittent Positive Pressure, Respiratory Failure, Extubation Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher \& Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow > 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above)
| Study group | Role | What they receive |
|---|---|---|
| nasal high frequency oscillatory ventilation | Experimental | 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% Receives: Device: Non-invasive ventilation |
| nasal synchronized intermittent positive pressure ventilation | Experimental | 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. Receives: Device: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study
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.
Measured: 2 hours after each intervention
Secondary outcomes (1)
Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.
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.
Measured: up to 7 days after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High-Frequency VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Controlled Crossover Study
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anucha Thatrimontrichai, Prince of Songkla University
- Investigators
- Anucha Thatrimontrichai, M.D., Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323397
- Sponsor's protocol ID
- 6238211
- Acronym
- nHFOnSIPPV
- Status last verified
- Feb 2025
- First submitted
- 25 Mar 2020
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37339671Phatigomet 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.
PubMed 37369239Baingam 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.
PubMed 38266755Phatigomet 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.
PubMed 38266756
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT04323397
- Acronym / sponsor ID
- nHFOnSIPPV / 6238211
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Crossover Study
| Arm | Type | Receives |
|---|---|---|
| nasal high frequency oscillatory ventilation | Experimental | Device: Non-invasive ventilationnHFO: 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 | Experimental | Device: Non-invasive ventilationnSIPPV: 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. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationIntervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher \& Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow > 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above) | Device | nasal high frequency oscillatory ventilation, nasal synchronized intermittent positive pressure ventilation |
Primary outcome
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.
1 secondary outcome
Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.
Time frame: up to 7 days after each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37339671Baingam 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.
- Results publication: PubMed 37369239Phatigomet 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.
- Results publication: PubMed 38266755Baingam 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.
- Results publication: PubMed 38266756Phatigomet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anucha Thatrimontrichai, M.D. principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation in people with High-Frequency Ventilation and Intermittent Positive-Pressure Ventilation, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study (time frame: 2 hours after each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323397, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.