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Given the high burden of respiratory distress syndrome (RDS) and its complications in resource-constrained settings, identifying effective, low-risk interventions is imperative. The study aimed to assess the improvement in oxygenation and ventilation parameters initiating non-invasive high-frequency oscillatory ventilation (nHFOV) or conventional mechanical ventilation (CMV) and to compare the incidence of air leaks, sepsis, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), prolonged hospital stays, and short-term survival rates.
Global neonatal care is moving toward lung-protective ventilation strategies to improve outcomes for preterm neonates. Evaluating the role of nHFOV in low- and middle-income countries (LMICs) like Pakistan not only helps address local healthcare challenges but also contributes to global efforts to optimize neonatal care across diverse settings. To best of my knowledge no such type of study has been conducted in Pakistan. This study is non-invasive and cost effective. The findings of this study could inform policy decisions and resource allocation in NICUs across Pakistan and other middle-income countries (LMICs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Invasive High-Frequency Oscillatory Ventilation Group | Experimental | Neonates were managed using a high-frequency oscillatory ventilator with a noninvasive nasal interface. Ventilator settings were adjusted to a mean airway pressure (MAP) of 8-12 cmH₂O, a frequency of 10 Hz, an amplitude adjusted to maintain optimal chest vibration, and an FiO₂ titrated to maintain SpO₂ between 90-94%. |
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| Conventional Ventilation Group | Experimental | Neonates received invasive ventilation through an endotracheal tube. Settings were adjusted to an initial tidal volume of 4-6 mL/kg, positive end-expiratory pressure (PEEP) of 4-6 cmH₂O, a respiratory rate of 30-50 breaths per minute, and FiO₂ titrated to maintain SpO₂ between 90-94%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive High-Frequency Oscillatory Ventilation | Procedure | Neonates were managed using a high-frequency oscillatory ventilator with a noninvasive nasal interface. Ventilator settings were adjusted to a mean airway pressure (MAP) of 8-12 cmH₂O, a frequency of 10 Hz, an amplitude adjusted to maintain optimal chest vibration, and an FiO₂ titrated to maintain SpO₂ between 90-94%. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in ventilation parameter | Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary dysplasia | Bronchopulmonary dysplasia was considered 'yes' if the patient required supplemental oxygen (>21% FiO₂) for ≥28 days to maintain oxygen saturation between 90-94%. | 36 weeks post-menstrual age |
| Sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Farhan, FCPS | Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh | Principal Investigator |
| Athar Razzaq, FCPS | Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh | Muzaffargarh | Punjab Province | 32400 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Conventional Mechanical Ventilation | Procedure | Neonates received invasive ventilation through an endotracheal tube. Settings were adjusted to an initial tidal volume of 4-6 mL/kg, positive end-expiratory pressure (PEEP) of 4-6 cmH₂O, a respiratory rate of 30-50 breaths per minute, and FiO₂ titrated to maintain SpO₂ between 90-94%. |
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At least 1 abnormality in laboratory findings of WBC <5,000/mm³, I/T ratio >0.2, and platelets <100,000/mm³. or CRP elevated (>10 mg/L), or procalcitonin elevated (>2 ng/mL). or blood gas analysis metabolic acidosis (pH <7.25) was taken as 'yes'.
| 28 days |
| Ventilator-Associated Pneumonia | Clinically, pneumonia was labeled 'yes' as a new or persistent respiratory distress or worsening gas exchange, increased ventilator requirements (e.g., higher FiO₂ or positive end-expiratory pressure [PEEP]), signs of infection (fever (>38°C) or hypothermia (<36°C), apnea or bradycardia episodes, tachycardia or hypotension). | 48 hours |
| Duration of respiratory support | Total days on modality were noted. | 28 days |
| Survival Status at Discharge | The survival status of the patient was noted as 'alive' or 'deceased'. | 28 days |