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Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
Sponsor: Aga Khan University
Summary
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe. The main questions it aims to answer are: Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support? Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital. Babies will: Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.
Official title: Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Primary Respiratory Support in Preterm Neonates With Respiratory Distress Syndrome: A Non Inferiority Randomized Controlled Trial
Key Details
Gender
All
Age Range
0 Hours - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2026-10-01
Completion Date
2027-12
Last Updated
2026-09-23
Healthy Volunteers
No
Interventions
Noninvasive High Frequency Oscillatory Ventilation
Noninvasive high frequency oscillatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an nHFOV capable ventilator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Mean airway pressure may be increased by 1 cmH₂O to a maximum of 20 cmH₂O, and amplitude may be increased by 5 cmH₂O to a maximum of 35 cmH₂O. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
Nasal Intermittent Mandatory Ventilation
Nasal intermittent mandatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an NIMV capable ventilator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. The respiratory rate may be increased by 5 breaths per minute to a maximum of 50 breaths per minute based on PaCO₂. FiO₂ and other ventilator settings may be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
Locations (1)
Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan
Karachi, Sindh, Pakistan