The goal of this clinical trial is to learn which breathing support works better after removing a newborn's breathing tube. Researchers will study newborns born at 26 weeks of gestation or later. Each newborn will have received breathing support through a tube for at least 24 hours.
The main questions it aims to answer are:
Does noninvasive high-frequency oscillatory ventilation (nHFOV) lower the need to replace the breathing tube within 72 hours? What breathing, feeding, or other medical problems occur with each type of support?
Researchers will compare nHFOV with nasal intermittent mandatory ventilation (NIMV). nHFOV provides very rapid pressure waves through the nose. NIMV provides regular, timed breaths through the nose. The researchers will compare these methods to see which works better after breathing tube removal.
Participants will:
Be assigned by chance to receive either nHFOV or NIMV Receive the assigned breathing support immediately after tube removal Have their breathing, oxygen level, and general condition closely monitored Have blood tests at 1, 12, and 24 hours post extubation to assess their breathing Be monitored for breathing pauses, feeding problems, and other medical problems during hospitalization
Gestational age at birth ≥26 weeks (inborn or outborn)
Postmenstrual age <44 weeks at enrollment according to NICU AKUH admission criteria
Intubation for respiratory distress or respiratory failure
Intubated for ≥24 hours
Birth weight <500 g
Major congenital anomaly affecting cardiac or respiratory function
Upper airway anomaly
Neuromuscular disorder affecting respiration
Parallel
Noninvasive High Frequency Oscillatory Ventilation
DevicenHFOV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O and may be increased in 1 cm H₂O steps to a maximum of 20 cm H₂O. Initial amplitude will be 15-25 cm H₂O and may be increased in 5 cm H₂O steps to a maximum of 35 cm H₂O. Frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Settings will be adjusted according to the participant's clinical condition.
Nasal Intermittent Mandatory Ventilation
DeviceNIMV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, and peak inspiratory pressure will be 18-24 cm H₂O. The initial breathing rate will be 30 breaths per minute and may be increased in steps of 5 to a maximum of 50 breaths per minute according to carbon dioxide levels and clinical assessment. Inspiratory time will be 0.5 seconds. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used.
Proportion of Participants With Extubation Failure Within 72 Hours
Extubation failure is defined as reintubation and return to invasive mechanical ventilation within 72 hours after planned extubation. Reintubation will be based on at least one prespecified criterion: pH below 7.20 with carbon dioxide above 65 mmHg, need for 60% or more oxygen to maintain the target oxygen saturation, an episode requiring bag mask ventilation, severe respiratory distress or a Silverman Anderson score of 7 or higher or cardiorespiratory arrest requiring cardiopulmonary resuscitation. The outcome will be reported as the number and percentage of participants with extubation failure in each group.
Proportion of Participants With Clinically Significant Apnea
Clinically significant apnea is defined as three or more breathing pauses within 72 hours after planned extubation that require tactile stimulation. The outcome will be reported as the number and percentage of participants meeting this criterion in each group.
Proportion of Participants With Feeding Intolerance
Feeding intolerance is defined as two consecutive gastric residual volumes greater than 50% of the previous feed volume, abdominal distension or vomiting that requires enteral feeding to be interrupted or modified for more than 24 hours while the participant is receiving the assigned respiratory support. The outcome will be reported as the number and percentage of participants with feeding intolerance in each group.
Post-extubation blood pH
Blood pH measured using an arterial or capillary blood gas sample. Values will be recorded and reported separately at 1, 12, and 24 hours after planned extubation. This is a component of the prespecified secondary outcome assessing post-extubation gas exchange and oxygenation.
Post-extubation partial pressure of carbon dioxide
Partial pressure of carbon dioxide (pCO₂), measured in mmHg using an arterial or capillary blood gas sample. Values will be recorded and reported separately at 1, 12, and 24 hours after planned extubation. This is a component of the prespecified secondary outcome assessing post-extubation gas exchange and oxygenation.
Time to Extubation Failure
Time in hours from planned extubation to reintubation and return to invasive mechanical ventilation during the first 72 hours. Participants who are not reintubated within 72 hours will be censored at 72 hours for this time-to-event analysis. Reintubation occurring after 72 hours and within 7 days will be recorded separately as an exploratory outcome.
Proportion of Participants With Air Leak Syndrome
The number and percentage of participants who develop an air-leak syndrome after planned extubation while receiving the assigned respiratory support. Air-leak syndromes include pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pneumopericardium, and subcutaneous emphysema confirmed radiologically or clinically. Events will be recorded until 7 days after planned extubation or discontinuation of the assigned intervention, whichever occurs first.
Proportion of Participants With Nasal Injury During the Assigned Intervention
The number and percentage of participants who develop nasal injury while receiving the assigned respiratory support. Nasal injury will be assessed using the Fischer grading system, ranging from grade 0 (no injury) to grade 3 (severe injury). Any injury of grade 1 or higher will be recorded.
Proportion of Participants Requiring Reintubation After 72 Hours and Within 7 Days
The number and percentage of participants who remain successfully extubated during the first 72 hours but subsequently require reintubation and return to invasive mechanical ventilation more than 72 hours and within 7 days after planned extubation.
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