Comparison of surfactant delivery methods - Endotracheal tube vs Laryngeal mask airway
Phase 4
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2023/07/054608
- Lead Sponsor
- Srikanth kandi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm neonates with respiratory distress syndrome on CPAP with requirement of FiO2 >0.3 and PEEP of 6cm H2O or more
Exclusion Criteria
Neonates intubated before enrolment
Major congenital malformations
Refusal to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success of surfactant delivery: attainment of following parameters within 60 minutes of delivery of Surfactant: <br/ ><br>1. FiO2 0.3 <br/ ><br>2. No / mild retractions <br/ ><br>3. RR: 80 bpm <br/ ><br>Timepoint: 60 minutes after surfactant delivery <br/ ><br>
- Secondary Outcome Measures
Name Time Method eed for invasive ventilation during 72 hrs following surfactant delivery <br/ ><br>Number of doses of surfactant required <br/ ><br>Time taken to perform the procedure <br/ ><br>Cumulative duration of respiratory support (non-invasive & invasive ventilation) during hospital stay <br/ ><br>Cumulative duration of following events during & within 10 minutes of the procedure <br/ ><br>a. Apnoea <br/ ><br>b. Preductal oxygen saturations below 85% <br/ ><br>c. Heart rate: bradycardia defined as HR 100 bpm <br/ ><br>Neonatal pain assessment with each procedure: This will be assessed by N-PASS scale <br/ ><br>Proceduralist stress score with each procedure by using Likert scale <br/ ><br>Incidence of IVH, Pneumothorax and BPD <br/ ><br>Amount of gastric leakage of surfactant <br/ ><br>Timepoint: Immediately after surfactant delivery & at discharge of the baby