To compare two techniques of surfactant administration in immature lungs of preterm babies
- Conditions
- Health Condition 1: J988- Other specified respiratory disorders
- Registration Number
- CTRI/2019/04/018701
- Lead Sponsor
- Prince pareek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Spontaneously breathing preterm infants with RDS diagnosed within 24 hours of life from >=28 weeks 0 days to 36 weeks 6 daysâ?? gestational age with respiratory distress syndrome who will meet two or more criteria for surfactant therapy
Those willing to participate in the study as consented by parents or relatives
Infants with anatomical abnormalities of upper airway or major congenital anomalies
Infants with conditions where nasal non-invasive ventilation is contraindicated such as â?? congenital diaphragmatic hernia, trachea-oesophageal fistula, choanal atresia, cleft palate and poor respiratory efforts
Infants whose FiO2 requirement is >=60% or hemodynamically unstable infants who require intubation and invasive ventilation for stabilization and therefore cannot be given non-invasive ventilation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the need for intubation and mechanical ventilation within 72 hours of birth (LISA versus INSURE) <br/ ><br> <br/ ><br>Timepoint: within 72 hours of birth <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate and compare between the two groups: <br/ ><br>1.Major complications <br/ ><br>2.Duration of mechanical ventilation <br/ ><br>3.Duration of non-invasive respiratory support <br/ ><br>4.Need for repeated surfactant administration <br/ ><br>5.Length of hospital stay <br/ ><br>6.Adverse events during surfactant administration <br/ ><br>Timepoint: during hospital stay