Effect of inhaled budesonide on duration of respiratory support in term neonates with meconium aspiration syndrome- A randomized controlled trial

The study will begin with the identification of eligible neonates, specifically term infants at 37 weeks gestation or more, with evidence of meconium-stained amniotic fluid or passage of meconium in utero with moderate to severe respiratory distress (as defined by Downe’s score greater than or equal to 4 or FiO2 greater than 0.4 within 6 hours of life). Neonates with congenital anomalies, congenital pneumonia, sepsis, at risk of early onset neonatal sepsis, severe birth asphyxia and neonates who require steroids for any other conditions  will be excluded. After obtaining informed consent from parents or guardians, the enrolled neonates will be randomized in a 1:1 ratio into two groups. Group A (intervention group, n equal to 50) will receive nebulized budesonide at a dose of 0.5 mg in 2.5 ml normal saline, with the first dose being administered within 6 hours of birth, followed by a second dose at 12 hours of life and then every 12 hourly till 3 days or until weaning from oxygen (whichever is earlier). Group B (control group, n equal to 50) will receive nebulized normal saline following the same schedule. Both groups will be monitored throughout a maximum of 72 hour intervention period, or until symptoms subside, whichever occurs sooner. During this time, all neonates in both the groups will receive standard supportive care, which includes oxygen therapy, CPAP and mechanical ventilation if required. Clinical parameters such as respiratory requirement, Downe’s score, oxygen requirement, blood glucose will be regularly assessed. The primary outcome measured will be the duration of respiratory support, while secondary outcomes include the length of NICU stay, duration of mechanical ventilation, incidence of complications like hyperglycemic episodes, sepsis, hypertension and ventilator associated pneumonia and mortality. Hyperglycemia will be treated with subcutaneous or intravenous insulin stat dose and hypertension (measured by oscillometric blood pressure apparatus 1hr apart ) will be treated with short course calcium channel blockers. If symptoms of new onset sepsis arise then the baby will be censored from the study at that point of time and will be appropriately treated for sepsis. At the conclusion of the intervention, data will be statistically analyzed to compare outcomes between the two groups, ultimately assessing the efficacy of early nebulized budesonide in managing meconium aspiration syndrome.

The recruitment of participants will be started after obtaining institute’s IEC approval and completion of CTRI registration.