Sardar Syamal, Pal Somnath, Ghosh Moumita
Department of Neonatology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Neonatology Division, Department of Pediatrics, Medical College and Hospital, Kolkata, West Bengal, 700054, India.
Indian J Pediatr. 2022 Dec;89(12):1195-1201. doi: 10.1007/s12098-022-04095-2. Epub 2022 May 3.
To compare the safety and efficacy of different nasal interfaces for delivering non invasive positive pressure ventilation (NIPPV) in preterm neonates.
In this three-arm parallel group stratified nonblinded randomized trial involving 210 preterm neonates the participants were randomly allocated to 'nasal mask', 'nasal prongs' and '4 hourly rotation of masks and prongs' groups in a 1:1:1 ratio. The groups were further stratified by gestational age (26-31 wk versus 32-36 wk) and indication of NIPPV (primary versus post extubation). Primary outcome was incidence of NIPPV failure within 72 h of initiation. Secondary outcomes were moderate/severe nasal injury, requirement of surfactant post randomization, total duration of respiratory support, duration of NICU stay, common neonatal morbidities and mortality.
Primary analysis revealed that mask group was superior to prongs and rotation groups in terms of reduction in NIPPV failure within 72 h (8.6%, 24.3%, 22.8%, p = 0.033), decreased incidence of moderate/severe nasal injury (8.6%, 22.8%, 11.4% p = 0.038), decreased requirement of surfactant (20%, 38.6%, 42.8%, p = 0.01) and reduction in total duration of respiratory support [median (interquartile range)-6 (3, 10) d, 7.7 (4.9, 19.2) d, 7 (5.5, 18.5) d, p = 0.005]. Post hoc analysis confirmed that nasal mask was superior to prongs with respect to primary outcome (p = 0.012) and also reduced surfactant requirement compared to both prongs (p = 0.015) and rotation (p = 0.003) groups. Other pairwise comparisons were not statistically significant.
Administering NIPPV by nasal mask significantly decreases the incidence of NIPPV failure within first 72 h compared to nasal prongs and also reduces the requirement of surfactant compared to both prongs and rotation groups.
比较不同鼻用接口在早产儿中进行无创正压通气（NIPPV）的安全性和有效性。
在这项三臂平行组分层非盲随机试验中，纳入210例早产儿，参与者按1:1:1的比例随机分配至“鼻面罩”、“鼻导管”和“面罩与鼻导管每4小时轮换”组。各组再按胎龄（26 - 31周与32 - 36周）和NIPPV指征（原发性与拔管后）进行分层。主要结局是开始NIPPV后72小时内NIPPV失败的发生率。次要结局包括中度/重度鼻损伤、随机分组后表面活性剂的使用需求、呼吸支持的总时长、新生儿重症监护病房（NICU）住院时长、常见的新生儿疾病及死亡率。
初步分析显示，在72小时内减少NIPPV失败方面，面罩组优于鼻导管组和轮换组（8.6%、24.3%、22.8%，p = 0.033），中度/重度鼻损伤的发生率降低（8.6%、22.8%、11.4%，p = 0.038），表面活性剂的使用需求减少（20%、38.6%、42.8%，p = 0.01），以及呼吸支持总时长缩短[中位数（四分位间距）- 6（3 , 10）天、7.7（4.9 , 19.2）天、7（5.5 , 18.5）天，p = 0.005]。事后分析证实，鼻面罩在主要结局方面优于鼻导管（p = 0.012），并且与鼻导管组（p = 0.015）和轮换组（p = 0.003）相比，表面活性剂使用需求也更低。其他两两比较无统计学意义。
与鼻导管相比，使用鼻面罩进行NIPPV在最初72小时内显著降低了NIPPV失败的发生率，并且与鼻导管组和轮换组相比，也降低了表面活性剂的使用需求。
