Comparing two techniques of lung Fluid administration in babies with breathing difficulty who are born before 37 weeks of pregnancy
Phase 3
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2019/10/021690
- Lead Sponsor
- ot Applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Neonates more than or equal to 26 weeks of gestation with Respiratory distress syndrome within 24 hours of life and spontaneously breathing on Nasal Continuous positive airway pressure who require surfactant treatment
Exclusion Criteria
1.Need for mechanical ventilation before enrollment
2.Major congenital malformation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidence of mechanical ventilation within 72 hours of life between both groups (Modified InSurE versus InSurE group)Timepoint: 72 hours of life
- Secondary Outcome Measures
Name Time Method 1.incidence of procedure related complications <br/ ><br>a) Apnea <br/ ><br>b) Bradycardia <br/ ><br>c).Desaturation <br/ ><br>2.Incidence of Surfactant reflux during procedure <br/ ><br> <br/ ><br>3.need for mechanical ventilation <br/ ><br> <br/ ><br>4.mortality <br/ ><br> <br/ ><br>5.Incidence of BPD as per NICHD. <br/ ><br> <br/ ><br>6.Duration of Hospital stay <br/ ><br> <br/ ><br>7.Incidence of grade 3 or 4 IVH before discharge. <br/ ><br>8.Total number of surfactant doses required <br/ ><br>Timepoint: 1. within 15 minutes <br/ ><br>2. during procedure <br/ ><br>3. within 72 hours <br/ ><br>4. before discharge <br/ ><br>5. before discharge <br/ ><br>6. before discharge <br/ ><br>7. before discharge <br/ ><br>8. within 24 hours