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Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation After Extubation in Neonates
Sponsor: Aga Khan University
Summary
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
Official title: Effectiveness of Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Post Extubation Respiratory Support in Neonates Born At ≥ 26 Weeks' Gestation: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
1 Day - 18 Weeks
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2026-10-01
Completion Date
2029-03-21
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Noninvasive High Frequency Oscillatory Ventilation
nHFOV 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
NIMV 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.
Locations (1)
Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan
Karachi, Sindh, Pakistan