Dhaka Aditi, Kumar Sonu, Singh Poonam, Priyadarshi Mayank, Chaurasia Suman, Bhat Nowneet Kumar, Basu Sriparna
Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
J Perinatol. 2024 Dec 17. doi: 10.1038/s41372-024-02201-0.
To compare the efficacy of nebulized salbutamol in reducing respiratory distress in late preterm and term neonates with transient tachypnea of newborn (TTN).
Double-blind, placebo-controlled randomized trial.
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 (FiO) after nebulization, duration of respiratory support, and adverse effects of salbutamol nebulization.
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, FiO requirement, and duration of respiratory support were similar. No adverse effect of salbutamol was documented.
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 registry of India, Registration no: CTRI/2023/05/052441, Registered prospectively on 10/05/2023, https://ctri.icmr.org.in/.
比较雾化沙丁胺醇对晚期早产儿和足月儿新生儿暂时性呼吸急促（TTN）时减轻呼吸窘迫的疗效。
双盲、安慰剂对照随机试验。
将患有TTN的新生儿（n = 134）分为雾化沙丁胺醇组（n = 67）和安慰剂组（生理盐水）（n = 67）。主要结局指标是呼吸急促的持续时间（呼吸频率>60次/分钟）。次要结局指标是雾化后最大唐斯评分和吸入氧分数（FiO）、呼吸支持的持续时间以及沙丁胺醇雾化的不良反应。
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随后均接受了正压呼吸支持。最大唐斯评分、FiO需求和呼吸支持的持续时间相似。未记录到沙丁胺醇的不良反应。
对于患有TTN的晚期早产儿和足月儿，雾化沙丁胺醇与安慰剂相比，呼吸急促的持续时间无差异。
印度临床试验注册中心，注册号：CTRI/2023/05/052441，于2023年5月10日前瞻性注册，https://ctri.icmr.org.in/ 。
