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

Journal of Perinatology volume 45, pages 1595–1600 (2025)Cite this article

Subjects

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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Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

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Acknowledgements

We wish to convey our sincere thanks to the neonatologists and NICU staff members at All India Institute of Medical Sciences, Rishikesh for participating in the study.

Author information

Authors and Affiliations

  1. Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India

    Aditi Dhaka, Sonu Kumar, Poonam Singh, Mayank Priyadarshi, Suman Chaurasia & Sriparna Basu

  2. Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India

    Aditi Dhaka & Nowneet Kumar Bhat

Authors
  1. Aditi Dhaka
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  2. Sonu Kumar
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  3. Poonam Singh
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  4. Mayank Priyadarshi
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  5. Suman Chaurasia
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  6. Nowneet Kumar Bhat
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  7. Sriparna Basu
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Contributions

Drs. Dhaka and Kumar recruited patients, collected and analyzed the data, and drafted the initial manuscript; Drs. Basu, Singh, and Priyadarshi supervised data collection and analysis of data and did critical revision and finalization of the manuscript; Drs. Chaurasia and Bhat contributed to the study design, data analysis and interpretation; and all authors approved the final manuscript as submitted.

Corresponding author

Correspondence to Sriparna Basu.

Ethics declarations

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.

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Patients signed informed consent regarding publishing their data and photographs.

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Dhaka, A., Kumar, S., Singh, P. et al. Nebulized salbutamol for the treatment of transient tachypnea of the newborn: a randomized controlled trial. J Perinatol 45, 1595–1600 (2025). https://doi.org/10.1038/s41372-024-02201-0

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