Nebulized salbutamol for the treatment of transient tachypnea of the newborn: a randomized controlled trial

Objective

To compare the efficacy of nebulized salbutamol in reducing respiratory distress in late preterm and term neonates with transient tachypnea of newborn (TTN).

Study design

Double-blind, placebo-controlled randomized trial.

Methods

Neonates with TTN (n = 134) were allocated to nebulized salbutamol (n = 67) versus placebo (normal saline) (n = 67). The primary outcome was the duration of tachypnea (respiratory rate >60/min). Secondary outcomes were maximum Downes score and fraction of inspired oxygen (FiO₂) after nebulization, duration of respiratory support, and adverse effects of salbutamol nebulization.

Results

Median duration of tachypnea was 12.5 (10–16) vs. 12 (10.4–14) hours in salbutamol and placebo groups, respectively; p = 0.489. Almost all neonates received positive-pressure respiratory support at delivery room and subsequently. Maximum Downe’s score, FiO₂ requirement, and duration of respiratory support were similar. No adverse effect of salbutamol was documented.

Conclusion

There was no difference in the duration of tachypnea with nebulized salbutamol compared to placebo in late preterm and term neonates with TTN.

Clinical trial registration

Clinical trial registry of India, Registration no: CTRI/2023/05/052441, Registered prospectively on 10/05/2023, https://ctri.icmr.org.in/