Zhou Rong, Xiong Tao, Tang Jun, Huang Yi, Liu Wenli, Zhu Jun, Chen Chao, Gong Lingyue, Tian Ke, Wang Aoyu, Mu Dezhi
Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University) Ministry of Education, Chengdu, China.
Trials. 2023 Oct 6;24(1):647. doi: 10.1186/s13063-023-07665-7.
Health problems in neonates with gestational age (GA) ≥ 32 weeks remain a major medical concern. Respiratory distress (RD) is one of the common reasons for admission of neonates with GA ≥ 32 weeks. Noninvasive ventilation (NIV) represents a crucial approach to treat RD, and currently, the most used NIV modes in neonatal intensive care unit include high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and nasal intermittent positive pressure ventilation. Although extensive evidence supports the use of NIPPV in neonates with a GA < 32 weeks, limited data exist regarding its effectiveness in neonates with GA ≥ 32 weeks. Therefore, the aim of this study is to compare the clinical efficacy of HFNC, CPAP, and NIPPV as primary NIV in neonates with GA ≥ 32 weeks who experience RD.
This trial is designed as an assessor-blinded, three-arm, multi-center, parallel, randomized controlled trial, conducted in neonates ≥ 32 weeks' GA requiring primary NIV in the first 24 h of life. The neonates will be randomly assigned to one of three groups: HFNC, CPAP or NIPPV group. The effectiveness, safety and comfort of NIV will be evaluated. The primary outcome is the occurrence of treatment failure within 72 h after enrollment. Secondary outcomes include death before discharge, surfactant treatment within 72 h after randomization, duration of both noninvasive and invasive mechanical ventilation, duration of oxygen therapy, bronchopulmonary dysplasia, time to achieve full enteral nutrition, necrotizing enterocolitis, duration of admission, cost of admission, air leak syndrome, nasal trauma, and comfort score.
Currently, there is a paucity of data regarding the utilization of NIPPV in neonates with GA ≥ 32 weeks. This study will provide clinical evidence for the development of respiratory treatment strategies in neonates at GA ≥ 32 weeks with RD, with the aim of minimizing the incidence of tracheal intubation and reducing the complications associated with NIV.
Chinese Clinical Trial Registry: ChiCTR2300069192. Registered on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=171491 .
胎龄（GA）≥32周的新生儿健康问题仍是主要的医学关注点。呼吸窘迫（RD）是GA≥32周新生儿入院的常见原因之一。无创通气（NIV）是治疗RD的关键方法，目前新生儿重症监护病房最常用的NIV模式包括高流量鼻导管（HFNC）、持续气道正压通气（CPAP）和鼻间歇正压通气。尽管有大量证据支持在GA<32周的新生儿中使用无创正压通气（NIPPV），但关于其在GA≥32周新生儿中的有效性的数据有限。因此，本研究的目的是比较HFNC、CPAP和NIPPV作为主要NIV在GA≥32周且发生RD的新生儿中的临床疗效。
本试验设计为一项评估者盲法、三臂、多中心、平行、随机对照试验，在GA≥32周且在出生后24小时内需要进行主要NIV的新生儿中进行。新生儿将被随机分配到三组之一：HFNC组、CPAP组或NIPPV组。将评估NIV的有效性、安全性和舒适性。主要结局是入组后72小时内治疗失败的发生情况。次要结局包括出院前死亡、随机分组后72小时内的表面活性剂治疗、无创和有创机械通气的持续时间、氧疗持续时间、支气管肺发育不良、实现完全肠内营养的时间、坏死性小肠结肠炎、住院时间、住院费用、气漏综合征、鼻外伤和舒适度评分。
目前，关于GA≥32周新生儿使用NIPPV的数据很少。本研究将为GA≥32周且患有RD的新生儿制定呼吸治疗策略提供临床证据，目的是尽量减少气管插管的发生率并减少与NIV相关的并发症。
中国临床试验注册中心：ChiCTR2300069192。于2023年3月9日注册，https://www.chictr.org.cn/showproj.html?proj=171491 。
