Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Spontaneously breathing preterm neonates between 26 and 35 weeks of gestation who will require surfactant therapy for Respiratory Distress Syndrome.
Exclusion criteria
Exclusion criteria: Babies who had a major congenital anomaly, with hemodynamic instability requiring inotropic support prior to randomization, had suffered severe asphyxia (Apgar score less than 4 at 5 minutes and/or requiring positive pressure ventilation for more than 2 minutes) and those who were already intubated at the time of first surfactant dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need of invasive ventilationTimepoint: Within 72 hours of surfactant administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (apnea, desaturation, bradycardia) Timepoint: At time of surfactant administration;Death before dischargeTimepoint: Before discharge;Duration of hospitalizationTimepoint: Before discharge;Duration of procedure Timepoint: At time of surfactant administration;Proportion of babies with BPD, ROP (needing treatment), NEC (greater than Stage 2a), IVH (greater than grade2)Timepoint: Before discharge;Requirement of invasive ventilation after 72 hoursTimepoint: Before discharge;Requirement of repeat surfactant dosage Timepoint: Within 24 hours;Total duration of respiratory support & invasive ventilationTimepoint: Before discharge | — |
Countries
India
Contacts
Government medical college and hospital, chandigarh