Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Lung Ultrasound guided surfactant administration group: Soon after randomization but not later than 2 hours from birth, a LUS will be performed by a trained neonatologist who is not inv
Sponsors
Prithiviraj Kesavan
Eligibility
Inclusion criteria
Inclusion criteria: Preterm neonates with more than 25 and less than32 weeks of gestational age. Respiratory distress since birth or onset within 2 hours from birth. Require continuous positive airway pressure support of at least 5 cm H2O and FiO2 of more than 0.21 to maintain preductal pulse saturation in 91 to 95% target range.
Exclusion criteria
Exclusion criteria: Major or life-threatening congenital anomalies. Hemodynamic instability requiring vasopressors or inotropes or inhaled nitric oxide. Requiring endotracheal intubation during resuscitation at birth or due to insufficient spontaneous respiratory efforts to initiate CPAP. Pulmonary air leaks (pneumothorax, pneumomediastinum) before the administration of first dose of surfactant. Refusal of consent by the parents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Composite outcome of BPD (as per Jensen et al criteria) or death(all cause, before discharge) at term equivalent age(40 weeks Post-Menstrual age) 2. Proportion of neonates with successful completion of the surfactant administration procedure in the first attempt Timepoint: 1. 40 weeks post menstrual age. 2. 72 hours of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of neonates who received surfactant early( less than 2 hrs of birth) & late( more than 2 hrs of birth)Timepoint: 72 hours of life;Proportion of neonates needing Invasive mechanical ventilation within first 3 days of lifeTimepoint: 72 hours of life;Max FiO2 level required to maintain preductal SpO2 between 91 to 95% before the administration of first dose of surfactantTimepoint: 72 hours of life;Need for second/repeat dose of surfactantTimepoint: 72 hours of life;Number of attempts for intratracheal catheter passageTimepoint: 72 hours of life;Need for multiple attempts for successful surfactant administrationTimepoint: 72 hours of life;Episodes of bradycardia during surfactant administration procedureTimepoint: 72 hours of life;Episodes of desaturation less than 80 percent during surfactant administration procedureTimepoint: 72 hours of life;Duration of non-invasive & invasive respiratory support before 40 weeks post menstrual age.Timepoint: 40 weeks Post menstrual age;Incidence of intubation during the surfactant administration procedureTimepoint: 72 hours of life;Proportion of neonates who had Pneumothorax post surfactant administrationTimepoint: 72 hours of life;Maximum FiO2 requirement during the hospital stayTimepoint: 40 weeks Post menstrual age;Duration of hospital stayTimepoint: 40 weeks Post menstrual age;Incidence of BPD & its severityTimepoint: 40 weeks Post menstrual age;Incidence of ROPTimepoint: 40 weeks Post menstrual age;Incidence of IVHTimepoint: 40 weeks Post menstrual age;Mortality rateTimepoint: 40 weeks Post menstrual age | — |
Countries
India
Contacts
Public ContactVenkataseshan Sundaram
PGIMER, Chandigarh
Outcome results
None listed