Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the need for intubation and mechanical ventilation within 72 hours of birth (LISA versus INSURE) Timepoint: within 72 hours of birth | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare between the two groups: 1. Major complications 2. Duration of mechanical ventilation 3. Duration of non-invasive respiratory support 4. Need for repeated surfactant administration 5. Length of hospital stay 6. Adverse events during surfactant administration Timepoint: during hospital stay | — |
Countries
India
Contacts
Bharati Vidyapeeth medical college, pune