Respiratory Distress Syndrome
Conditions
Brief summary
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.
Detailed description
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).
Interventions
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%.
PROCEDUREConventional Mechanical Ventilation
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%.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Neonates of any gender * Gestational age between 26 and 36 weeks * Diagnosed with RDS. * Failed to respond to nCPAP treatment
Exclusion criteria
* Major congenital anomalies like congenital diaphragmatic hernia, dysmorphism and congenital heart diseases * Early onset sepsis at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in ventilation parameter | 24 hours | Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonary dysplasia | 36 weeks post-menstrual age | Bronchopulmonary dysplasia was considered 'yes' if the patient required supplemental oxygen (\>21% FiO₂) for ≥28 days to maintain oxygen saturation between 90-94%. |
| Sepsis | 28 days | 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'. |
| Ventilator-Associated Pneumonia | 48 hours | 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). |
| Duration of respiratory support | 28 days | Total days on modality were noted. |
| Survival Status at Discharge | 28 days | The survival status of the patient was noted as 'alive' or 'deceased'. |
Countries
Pakistan
Outcome results
None listed