Nebulized salbutamol for the treatment of transient tachypnea of the newborn: a randomized controlled trial
- PMID: 39690178
- DOI: 10.1038/s41372-024-02201-0
Nebulized salbutamol for the treatment of transient tachypnea of the newborn: a randomized controlled trial
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/.
© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.
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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