To look for the use of high frequency oscillatory ventilation for reducing the rates of intubatio
Phase 2
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2024/04/066150
- Lead Sponsor
- Dr Sonali Amol Avale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
2. Major congenital malformations or known complex congenital heart disease.
3. Refusal to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groupsTimepoint: first 72 hours of life
- Secondary Outcome Measures
Name Time Method 1.Days of hospitalization, <br/ ><br>2.Days on NIV, <br/ ><br>3.Days on supplemental oxygen, <br/ ><br>4.Pre-discharge mortality, <br/ ><br>5.Surfactant doses, <br/ ><br>6.Retinopathy of prematurity, <br/ ><br>7.Bronchopulmonary dysplasia , <br/ ><br>8.Abdominal distention, feed intolerance, time to full feed, air leaks <br/ ><br>9. Intraventricular hemorrhage , <br/ ><br>10.Spontaneous intestinal perforation, <br/ ><br>11.Presence of thick secretions causing an airway obstruction <br/ ><br>Timepoint: Death <br/ ><br>Discharge