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.
Preterm neonates born between 28+0 and 36+0 weeks of gestation, whether inborn or outborn
Gestational age confirmed by first-trimester ultrasound, last menstrual period, or Ballard score
Clinical and radiological evidence of respiratory distress syndrome
Requirement for NIMV-level noninvasive respiratory support according to the protocol-defined criteria
Intubation and receipt of invasive mechanical ventilation at the time of enrollment
Receipt of surfactant before randomization by any method, including INSURE, LISA, MIST, or surfactant administration before transfer to Aga Khan University Hospital
Major congenital anomaly affecting respiratory or cardiovascular physiology
Parallel
Noninvasive High Frequency Oscillatory Ventilation
DeviceNoninvasive 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
DeviceNasal 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%.
Proportion of preterm neonates with treatment failure requiring invasive mechanical ventilation
Treatment failure is defined as initiation of invasive mechanical ventilation due to any of the following: pH \<7.20 with pCO₂ \>60 mmHg on two blood gas measurements at least 30 minutes apart, SpO₂ \<90% with FiO₂ \>0.60 for at least 15 minutes on maximal noninvasive support; at least one apnea episode requiring bag mask ventilation; Silverman Anderson Score ≥7 on maximal noninvasive support; hemodynamic instability requiring inotropic support secondary to respiratory failure, or the physician's decision to intubate for clinical reasons with written justification. The number and proportion of neonates meeting the treatment failure criteria will be reported in each study arm.
Proportion of Eligible Neonates With Bronchopulmonary Dysplasia at 36 Weeks' Postmenstrual Age Description
Among enrolled neonates born at ≤32 weeks' gestation who survive to 36 weeks' PMA, BPD will be classified according to respiratory support at 36 weeks using Jensen et al. (2019): no BPD, no respiratory support; Grade 1, nasal cannula ≤2 L/min; Grade 2, nasal cannula \>2 L/min or noninvasive positive-pressure support; and Grade 3, invasive mechanical ventilation. Respiratory status will be obtained from inpatient records, outpatient assessment, or telephone follow-up. Neonates who die before 36 weeks' PMA will be excluded from BPD ascertainment.
Proportion of eligible neonates with severe intraventricular hemorrhage
The proportion of enrolled neonates born at \<32 weeks' gestation or with a birth weight \<1,500 g who develop severe IVH will be reported for each study arm. Severe IVH is defined according to the Papile classification as Grade III, IVH occupying ≥50% of the ventricular area with ventricular dilatation, or Grade IV, IVH with periventricular echodensity consistent with periventricular hemorrhagic infarction. All routine and clinically indicated cranial ultrasounds obtained during the assessment period will be included and reported by a consultant radiologist blinded to treatment allocation.
Proportion of Eligible Neonates With Treatment-Requiring Retinopathy of Prematurity
The proportion of enrolled neonates born at \<32 weeks' gestation or with a birth weight \<1,500 g who develop treatment-requiring ROP in either eye will be reported for each study arm. Screening will be performed by a consultant ophthalmologist, and ROP will be classified according to ICROP3. Treatment-requiring ROP is defined as Type 1 ROP-Zone I ROP of any stage with plus disease, Zone I Stage 3 without plus disease, or Zone II Stage 2 or 3 with plus disease-aggressive ROP, or Stage 4 or 5 ROP. Treatment may include laser photocoagulation, intravitreal anti-VEGF therapy, or vitreoretinal surgery. Findings will be obtained from inpatient records and scheduled post-discharge ophthalmology follow-up.
Duration of noninvasive respiratory support
The cumulative duration for which each participant receives noninvasive respiratory support after randomization will be recorded and reported in days, including the assigned nHFOV or NIMV intervention and any subsequent noninvasive positive pressure respiratory support. Heated humidified high flow nasal cannula and supplemental oxygen alone will not be included. The duration will be compared between the two study arms.
Duration of invasive mechanical ventilation
Among participants who require intubation and invasive mechanical ventilation after randomization, the cumulative duration of all invasive mechanical ventilation episodes will be recorded and reported in days. The duration will be compared between the nHFOV and NIMV study arms.
Duration of supplemental oxygen therapy
The cumulative duration for which each participant receives supplemental oxygen after randomization will be recorded and reported in days. This will include supplemental oxygen delivered through invasive mechanical ventilation, noninvasive respiratory support, heated humidified high-flow nasal cannula, low-flow nasal cannula, oxygen hood, or any other oxygen delivery device. The duration will be compared between the nHFOV and NIMV study arms.
Proportion of neonates receiving surfactant after randomization
The number and proportion of neonates who receive at least one dose of surfactant after randomization will be recorded and compared between the nHFOV and NIMV study arms.
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