Early (≤ 2 h) Bolus Surfactant Replacement Therapy Versus Standard Care in Term (≥ 37 Weeks) Neonates With Meconium Aspiration Syndrome: An Open-Label Randomized Controlled Trial.

BACKGROUND

Meconium aspiration syndrome (MAS), a common cause of respiratory failure in late preterm and term neonates, is associated with a high risk of mortality and morbidity. Amongst all the treatment modalities for severe MAS, surfactant administration has a proven role in decreasing progressive respiratory failure.

METHODS

The present open-label randomised controlled trial aimed to determine the effect of early (≤ 2 h) bolus surfactant therapy as compared to standard care on the total duration of respiratory support. Term (≥ 37 weeks) neonates with MAS who had respiratory distress (Downes ≥ 4, and FiO2 ≥ 0.5 despite the effective CPAP support) with radiological evidence of MAS received either bolus surfactant or standard care within 2 h after birth. The primary endpoint was the total duration of respiratory support (i.e. both invasive and Noninvasive ventilation).

RESULTS

Sixty neonates were enrolled in the study, 30 each in the surfactant group and standard care group, respectively. Baseline characteristics were similar between the two groups. The median (IQR) total duration of respiratory support was significantly lower in the surfactant group (48 [24-120] h vs. 132 [66-234] h; mean difference, 84 h; 95% CI: 31.6 to 136.3; p: 0.005 respectively). There was a significant reduction in the requirement of both invasive and Noninvasive ventilation. Other clinical parameters like mortality, the incidence of air leak, persistent pulmonary hypertension, hypoxic-ischemic encephalopathy, and pulmonary hemorrhage were comparable between both groups.

CONCLUSION

Early bolus surfactant replacement therapy significantly reduces the total duration of respiratory support among term neonates with MAS without increasing adverse outcome.