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Randomized Controlled Trial
. 2025 Nov;45(11):1595-1600.
doi: 10.1038/s41372-024-02201-0. Epub 2024 Dec 17.

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

Aditi Dhaka  1   2 , Sonu Kumar  1 , Poonam Singh  1 , Mayank Priyadarshi  1 , Suman Chaurasia  1 , Nowneet Kumar Bhat  2 , Sriparna Basu  3
Affiliations
Randomized Controlled Trial

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

Aditi Dhaka et al. J Perinatol. 2025 Nov.

Abstract

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/.

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Conflict of interest statement

Competing interests: The authors declare no competing interests. Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. The study protocol was approved by the Institute’s Ethics Committee of AIIMS Rishikesh, Uttarakhand, India (Ref No: AIIMS/IEC/23/143, dated 28/04/2023). Consent to participate: Written informed consent was obtained from the parents of each subject before enrolment. Consent for publication: Patients signed informed consent regarding publishing their data and photographs.

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