An interventional study of Non-invasive ventilation in High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation and Newborn Morbidity, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 1 Day to 1 Month. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment
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.
The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.
Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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%
Device: 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.
Device: Non-invasive ventilation
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)
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.
Time frame: 2 hours after each intervention
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.
Time frame: up to 7 days after each intervention
Overall, 203 neonates were assessed for eligibility
| Milestone | "nHFO First, Then nSIPPV, Then nHFO" | "nSIPPV First, Then nHFOV, Then nSIPPV" |
|---|---|---|
| Started | 51 | 51 |
| Completed | 51 | 51 |
| Not completed | 0 | 0 |
| Milestone | "nHFO First, Then nSIPPV, Then nHFO" | "nSIPPV First, Then nHFOV, Then nSIPPV" |
|---|---|---|
| Started | 51 | 51 |
| Completed | 51 | 51 |
| Not completed | 0 | 0 |
| Milestone | "nHFO First, Then nSIPPV, Then nHFO" | "nSIPPV First, Then nHFOV, Then nSIPPV" |
|---|---|---|
| Started | 67 | 66 |
| Completed | 67 | 66 |
| Not completed | 0 | 0 |
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.
| mm Hg | nHFO | nSIPPV |
|---|---|---|
| Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study | 38.7 ± 8.8 | 36.8 ± 10.2 |
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.
| Participants | nHFO | nSIPPV |
|---|---|---|
| Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study. | 5 | 4 |
Collected over Adverse event: "Crossover Phase: up to 4 hours, Parallel Phase: up to 7 days after intervention". Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parallel: Nasal High Frequency Oscillatory Ventilation | 0/67 (0%) | 5/67 (7.5%) | 0/67 (0%) |
| Parallel: Nasal Synchronized Intermittent Positive Pressure Ventilation | 0/66 (0%) | 4/66 (6.1%) | 0/66 (0%) |
| Crossover: Nasal High Frequency Oscillatory Ventilation | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
| Crossover: Nasal Synchronized Intermittent Positive Pressure Ventilation | 0/102 (0%) | 1/102 (1%) | 0/102 (0%) |
| Event | Parallel: Nasal High Frequency Oscillatory Ventilation | Parallel: Nasal Synchronized Intermittent Positive Pressure Ventilation | Crossover: Nasal High Frequency Oscillatory Ventilation | Crossover: Nasal Synchronized Intermittent Positive Pressure Ventilation |
|---|---|---|---|---|
| Adverse Event after started interventionRespiratory, thoracic and mediastinal disorders | 5/67 | 4/66 | 0/102 | 1/102 |
| Age, Continuous(weeks) | nHFOV, Then nSIPPV, Then nHFOV | nSIPPV, Then nHFOV, Then nSIPPV | Total |
|---|---|---|---|
| Median | 33 (30 to 35) | 33 (30 to 37) | 33 (30 to 37) |
| Sex: Female, Male(Participants) | nHFOV, Then nSIPPV, Then nHFOV | nSIPPV, Then nHFOV, Then nSIPPV | Total |
|---|---|---|---|
| Female | 20 | 32 | 52 |
| Male | 47 | 34 | 81 |
| Race and Ethnicity Not Collected(Participants) | nHFOV, Then nSIPPV, Then nHFOV | nSIPPV, Then nHFOV, Then nSIPPV | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Duration of invasive ventilation(hours) | nHFOV, Then nSIPPV, Then nHFOV | nSIPPV, Then nHFOV, Then nSIPPV | Total |
|---|---|---|---|
| Median | 63.4 (21.2 to 95.2) | 42.9 (21.7 to 84.1) | 48.4 (21.3 to 90.8) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prince of Songkla University