R D Rachana, Tejopratap Oleti, D Saikiran, Venkateshwarlu Vardhelli, Sruthi Thiruveedi, Altaf Hussain, Prasen Reddy Tamatam
{"title":"无创高频振荡通气与无创间歇强制通气作为鼻部cpap呼吸窘迫早产儿的抢救模式——一项随机对照试验","authors":"R D Rachana, Tejopratap Oleti, D Saikiran, Venkateshwarlu Vardhelli, Sruthi Thiruveedi, Altaf Hussain, Prasen Reddy Tamatam","doi":"10.1007/s00431-025-06041-8","DOIUrl":null,"url":null,"abstract":"<p><p>To compare NHFOV in decreasing the need for mechanical ventilation in the first 7 days of randomization in preterm infants born before 34 weeks of gestational age having nCPAP failure when used as rescue mode compared to NIMV. All eligible neonates were randomized and allocated to either NHFOV or NIMV group after taking the consent from the parents. Standardized protocol was followed on initiation, titration, weaning, and optimization of all the respiratory supports. In this study, a total of 45 neonates were eligible; among them, 20 neonates were randomized to NIMV group and 20 neonates to NHFOV group remaining 5 infants were missed due to the non-availability of a machine (n = 4) and missed randomization (n = 1). The primary outcome was need for mechanical ventilation within first 7 days of randomization in NIMV and NHFOV group was 45% and 40% (p = 0.85, OR = 1.22 (CI 0.35-4.3)). The secondary outcome was a duration of ventilation within 72 h of randomization was 40% vs. 31.6% in NIMV and NHFOV group (p = 0.58). Bronchopulmonary dysplasia was 5% and 10% in NIMV and NHFOV group with p = 0.548, OR = 0.47 (CI 0.39-5.6), and mortality was one infant in NIMV and 3 infants in NHFOV group (p = 0.568, OR = 0.29 (CI 0.02-3.1)).</p><p><strong>Conclusion: </strong>NIMV and NHFOV are comparable in reducing the rates of mechanical ventilation within 72 h and within 7 days of post-randomization. Multi-centric trials with large sample sizes are required to prove the hypothesis.</p><p><strong>Trial registration: </strong>www.ctri.nic.in id CTRI/2021/10/037681, registered on October 29, 2021.</p><p><strong>What is known: </strong>• NIMV or nHFOV being used as primary as well as post extubation respiratory support in neonates. • NIMV and nHFOV has shown better clinical outcomes than nCPAP when used as primary and post extubation respiratory support.</p><p><strong>What is new: </strong>• NIMV and nHFOV can be used as rescue mode after CPAP failure to prevent need for mechanical ventilation. • nHFOV appears promising as rescue mode in neonates who meets CPAP failure criteria.</p>","PeriodicalId":11997,"journal":{"name":"European Journal of Pediatrics","volume":"184 3","pages":"205"},"PeriodicalIF":2.6000,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Non-invasive high-frequency oscillatory ventilation versus non-invasive intermittent mandatory ventilation as a rescue mode in preterm infants with respiratory distress on nasal CPAP-a randomized control trial.\",\"authors\":\"R D Rachana, Tejopratap Oleti, D Saikiran, Venkateshwarlu Vardhelli, Sruthi Thiruveedi, Altaf Hussain, Prasen Reddy Tamatam\",\"doi\":\"10.1007/s00431-025-06041-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>To compare NHFOV in decreasing the need for mechanical ventilation in the first 7 days of randomization in preterm infants born before 34 weeks of gestational age having nCPAP failure when used as rescue mode compared to NIMV. All eligible neonates were randomized and allocated to either NHFOV or NIMV group after taking the consent from the parents. Standardized protocol was followed on initiation, titration, weaning, and optimization of all the respiratory supports. In this study, a total of 45 neonates were eligible; among them, 20 neonates were randomized to NIMV group and 20 neonates to NHFOV group remaining 5 infants were missed due to the non-availability of a machine (n = 4) and missed randomization (n = 1). The primary outcome was need for mechanical ventilation within first 7 days of randomization in NIMV and NHFOV group was 45% and 40% (p = 0.85, OR = 1.22 (CI 0.35-4.3)). The secondary outcome was a duration of ventilation within 72 h of randomization was 40% vs. 31.6% in NIMV and NHFOV group (p = 0.58). Bronchopulmonary dysplasia was 5% and 10% in NIMV and NHFOV group with p = 0.548, OR = 0.47 (CI 0.39-5.6), and mortality was one infant in NIMV and 3 infants in NHFOV group (p = 0.568, OR = 0.29 (CI 0.02-3.1)).</p><p><strong>Conclusion: </strong>NIMV and NHFOV are comparable in reducing the rates of mechanical ventilation within 72 h and within 7 days of post-randomization. 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引用次数: 0
摘要
比较NHFOV与NIMV相比,在随机分组的前7天内,在34周龄前出生的nCPAP失败的早产儿中,减少机械通气需求。在征得父母同意后,将所有符合条件的新生儿随机分为NHFOV组和NIMV组。所有呼吸支持的启动、滴定、脱机和优化均遵循标准化方案。本研究共纳入45例新生儿;其中20例新生儿随机分为NIMV组,20例新生儿随机分为NHFOV组,其余5例新生儿因无机(n = 4)和未随机化(n = 1)而错过。NIMV组和NHFOV组的主要终点是随机分组后7天内机械通气需要量分别为45%和40% (p = 0.85, OR = 1.22 (CI 0.35-4.3))。次要结果是随机分组后72小时内的通气持续时间为40%,NIMV组为31.6%,NHFOV组为31.6% (p = 0.58)。NIMV组和NHFOV组的支气管肺发育不良发生率分别为5%和10%,p = 0.548, OR = 0.47 (CI 0.39 ~ 5.6), NIMV组的死亡率分别为1例和3例(p = 0.568, OR = 0.29 (CI 0.02 ~ 3.1))。结论:NIMV和NHFOV在随机分组后72 h和7天内降低机械通气率方面具有可比性。需要大样本量的多中心试验来证明这一假设。试验注册:www.ctri.nic.in id CTRI/2021/10/037681,于2021年10月29日注册。•NIMV或nHFOV被用作新生儿拔管后的初级呼吸支持。•NIMV和nHFOV作为拔管初期和拔管后呼吸支持的临床效果优于nCPAP。创新点:•在CPAP故障后,NIMV和nHFOV可作为救援模式,以防止需要机械通气。•对于符合CPAP失败标准的新生儿,nHFOV似乎是一种有希望的抢救模式。
Non-invasive high-frequency oscillatory ventilation versus non-invasive intermittent mandatory ventilation as a rescue mode in preterm infants with respiratory distress on nasal CPAP-a randomized control trial.
To compare NHFOV in decreasing the need for mechanical ventilation in the first 7 days of randomization in preterm infants born before 34 weeks of gestational age having nCPAP failure when used as rescue mode compared to NIMV. All eligible neonates were randomized and allocated to either NHFOV or NIMV group after taking the consent from the parents. Standardized protocol was followed on initiation, titration, weaning, and optimization of all the respiratory supports. In this study, a total of 45 neonates were eligible; among them, 20 neonates were randomized to NIMV group and 20 neonates to NHFOV group remaining 5 infants were missed due to the non-availability of a machine (n = 4) and missed randomization (n = 1). The primary outcome was need for mechanical ventilation within first 7 days of randomization in NIMV and NHFOV group was 45% and 40% (p = 0.85, OR = 1.22 (CI 0.35-4.3)). The secondary outcome was a duration of ventilation within 72 h of randomization was 40% vs. 31.6% in NIMV and NHFOV group (p = 0.58). Bronchopulmonary dysplasia was 5% and 10% in NIMV and NHFOV group with p = 0.548, OR = 0.47 (CI 0.39-5.6), and mortality was one infant in NIMV and 3 infants in NHFOV group (p = 0.568, OR = 0.29 (CI 0.02-3.1)).
Conclusion: NIMV and NHFOV are comparable in reducing the rates of mechanical ventilation within 72 h and within 7 days of post-randomization. Multi-centric trials with large sample sizes are required to prove the hypothesis.
Trial registration: www.ctri.nic.in id CTRI/2021/10/037681, registered on October 29, 2021.
What is known: • NIMV or nHFOV being used as primary as well as post extubation respiratory support in neonates. • NIMV and nHFOV has shown better clinical outcomes than nCPAP when used as primary and post extubation respiratory support.
What is new: • NIMV and nHFOV can be used as rescue mode after CPAP failure to prevent need for mechanical ventilation. • nHFOV appears promising as rescue mode in neonates who meets CPAP failure criteria.
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