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

IF 2.4 3区医学 Q2 OBSTETRICS & GYNECOLOGY Journal of Perinatology Pub Date : 2024-12-17 DOI:10.1038/s41372-024-02201-0

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

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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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沙丁胺醇雾化治疗新生儿短暂性呼吸急促：一项随机对照试验。

目的：比较雾化沙丁胺醇减轻晚期早产儿和足月新生儿短暂性呼吸急促（TTN）呼吸窘迫的疗效。研究设计：双盲、安慰剂对照的随机试验。方法：将134例TTN患儿分为沙丁胺醇雾化组（n = 67）和生理盐水安慰剂组（n = 67）。主要观察指标为呼吸急促持续时间（呼吸频率bbb60 /min）。次要结果为最大唐斯评分和雾化后吸入氧（FiO2）分数、呼吸支持持续时间和沙丁胺醇雾化的不良反应。结果：沙丁胺醇组和安慰剂组呼吸急促的中位持续时间分别为12.5（10-16）小时和12（10.4-14）小时；p = 0.489。几乎所有新生儿在产房及其后均接受了正压呼吸支持。最大唐氏评分、FiO2需要量和呼吸支持时间相似。沙丁胺醇无不良反应。结论：与安慰剂相比，雾化沙丁胺醇对晚期早产儿和足月新生儿TTN的呼吸急促持续时间无显著差异。临床试验注册：印度临床试验注册中心，注册号：CTRI/2023/05/052441，预计2023年5月10日注册，https://ctri.icmr.org.in/。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Perinatology 医学-妇产科学

CiteScore

5.40

自引率

6.90%

发文量

284

审稿时长

3-8 weeks

期刊介绍： The Journal of Perinatology provides members of the perinatal/neonatal healthcare team with original information pertinent to improving maternal/fetal and neonatal care. We publish peer-reviewed clinical research articles, state-of-the art reviews, comments, quality improvement reports, and letters to the editor. Articles published in the Journal of Perinatology embrace the full scope of the specialty, including clinical, professional, political, administrative and educational aspects. The Journal also explores legal and ethical issues, neonatal technology and product development. The Journal’s audience includes all those that participate in perinatal/neonatal care, including, but not limited to neonatologists, perinatologists, perinatal epidemiologists, pediatricians and pediatric subspecialists, surgeons, neonatal and perinatal nurses, respiratory therapists, pharmacists, social workers, dieticians, speech and hearing experts, other allied health professionals, as well as subspecialists who participate in patient care including radiologists, laboratory medicine and pathologists.