Noninvasive high frequency oscillatory ventilation versus Noninvasive intermittent positive pressure ventilation as a primary respiratory support in preterms with respiratory distress syndrome- A Randomized Control Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Sonali Amol Avale
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groups
Overview
Brief Summary
Invasive ventilation (IV) is a key procedure to reduce respiratory mortality and morbidity in preterm infants with respiratory distress syndrome (RDS). However, it is associated with the increased risks of bronchopulmonary dysplasia (BPD) ,re-hospitalization, and brain injury among the survivors .Nasal high-frequency oscillatory ventilation (NHFOV) appears to combine the advantages of continuous distending pressure and non-invasive ventilation without need for synchronization and may reduce the incidence of intubation in preterm infants with RDS. A multicentre study has indicated that NHFOV is related to the reducednumbers of apnea, bradycardia, and oxygen desaturation as a remedial measure after failing other noninvasive modes in preterm infants. Hence the purpose of this study is to compare efficacy of noninvasive high frequency ventilation versus non invasive intermittent positive pressure ventilation in preterms with respiratory distress syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Day(s) to 1.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Gestational age (GA) is between 26 and less than 34 weeks.
- •GA will be determined by dates or a dating ultrasound.
- •If not available- New Ballards score will be used to determine gestational age Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting) within the first 1 hour of life.
- •Chest Xray will be done within 1 hour of life .
- •Informed parental consent.
Exclusion Criteria
- •1.Any baby intubated for resuscitation or for other reasons.
- •Major congenital malformations or known complex congenital heart disease.
- •Refusal to consent.
Outcomes
Primary Outcomes
Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groups
Time Frame: first 72 hours of life
Secondary Outcomes
- 1. Days of hospitalization,(2. Days on NIV,)
Investigators
Dr Sonali Amol Avale
Government Medical college , Sambhaji Nagar