Effectiveness of Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation vs Noninvasive High-Frequency Oscillatory Ventilation as Support After Extubation of Neonates Born Extremely Preterm or With More Severe Respiratory Failure A Secondary Analysis of a Randomized Clinical Trial

作者全名："Zhu, Xingwang; Li, Fang; Shi, Yuan; Feng, Zhichun; De Luca, Daniele"

作者地址："[Zhu, Xingwang; Shi, Yuan] Chongqing Med Univ, Minist Educ, Key Lab Child Dev & Disorders, Childrens Hosp,Key Lab Pediat, Chongqing, Peoples R China; [Zhu, Xingwang] Bishan Maternal & Child Hlth Care Hosp, Chongqing, Peoples R China; [Li, Fang] Chongqing Med Univ, Women & Childrens Hosp, Chongqing, Peoples R China; [Feng, Zhichun] Chinese Peoples Liberat Army Gen Hosp, Dept Neonatol, Fac Pediat, Med Ctr 7, Beijing, Peoples R China; [De Luca, Daniele] Paris Saclay Univ Hosp, APHP, Med Ctr A Beclere, Div Pediat & Neonatal Crit Care, Paris, France; [De Luca, Daniele] Paris Saclay Univ, INSERM, U999 Unit, Physiopathol & Therapeut Innovat, Paris, France"

通信作者："Feng, ZC (通讯作者)，Chinese Peoples Liberat Army Gen Hosp, Dept Neonatol, Fac Pediat, Med Ctr 7, Nanmencang 5th 33, Beijing 100010 34, Peoples R China."

来源：JAMA NETWORK OPEN

ESI学科分类：　

WOS号：WOS:001061812500007

JCR分区：Q1

影响因子：10.5

年份：2023

卷号：6

期号：7

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："IMPORTANCE The NASONE (Nasal Oscillation Post-Extubation) trial showed that noninvasive high-frequency oscillatory ventilation (NHFOV) slightly reduces the duration of invasive mechanical ventilation (IMV) in preterm infants, whereas NHFOV and noninvasive intermittent positive pressure ventilation (NIPPV) result in fewer reintubations than nasal continuous positive airway pressure (NCPAP). It is unknown whether NHFOV is similarly effective in extremely preterm neonates or in those with more severe respiratory failure (based on the duration of previous ventilation and CO2 levels). OBJECTIVE To clarify whether NHFOV is better than NIPPV and NCPAP in reducing the duration of IMV in extremely preterm neonates or those with severe respiratory failure. DESIGN, SETTING, AND PARTICIPANTS This study is a predefined secondary analyses of a multicenter randomized clinical trial that was performed at tertiary academic neonatal intensive care units (NICUs) in China. Participants included neonates enrolled in the NASONE trial between December 2017 and May 2021 and belonging to 3 predefined subgroups: (1) born at less than or equal to 28 weeks' (plus 6 days) gestation, (2) invasively ventilated for more than 1 week from birth, and (3) with CO2 greater than 50 mm Hg before or in the 24 hours after extubation. Data analysis was performed in August 2022. INTERVENTION NCPAP, NIPPV, or NHFOV since the first extubation and until NICU discharge, with airway pressure higher in NHFOV than in NIPPV and than in NCPAP. MAIN OUTCOMES AND MEASURES The co-primary outcomes were total duration of IMV during the NICU stay, need for reintubation, and ventilator-free days calculated as per the original trial protocol. Outcomes were analyzed on an intention-to-treat basis as for the whole trial, and subgroup analyses followed the original statistical plan. RESULTS Among 1137 preterm infants, 455 (279 boys [61.3%]) were born at 28 weeks' gestation or less, 375 (218 boys [58.1%]) underwent IMV for more than 1 week from birth, and 307 (183 boys [59.6%]) had CO2 greater than 50mmHg before or in the 24 hours after extubation. Both NIPPV and NHFOVwere associated with significantly fewer reintubations (risk difference range, -28%[95% CI, -39% to -17%] to -15%[95% CI, -25% to -4%]; number needed to treat, 3-7 infants) and early reintubations (risk difference range, -24%[95% CI, -35% to -14%] to -20%[95% CI, -30% to -10%]) than NCPAP, and these reintubations were less frequently due to refractory hypoxemia. IMV was shorter in the NIPPV and NHFOV groups (mean difference range, -5.0 days [95% CI, -6.8 to -3.1 days] to -2.3 days [95% CI, -4.1 to -0.4 days]) than in the NCPAP group. Co-primary outcomes were not different between NIPPV and NHFOV; there was no significant interaction effect. Infants in the NHFOV group showed significantly less moderate-to-severe bronchopulmonary dysplasia than infants in the NCPAP group (range, -12% to -10%; number needed to treat, 8-9 infants) and better postextubation gas exchange in all subgroups. The 3 interventions were provided at different mean airway pressure and were equally safe. CONCLUSIONS AND RELEVANCE The subgroup analyses of extremely preterm or more ill infants confirm the results obtained in the whole population: NIPPV and NHFOV appeared equally effective in reducing duration of IMV compared with NCPAP."

基金机构：Scientific Research Projects Unit of Chongqing Medical University [Project-cstc2016shms-ztzx13001]

基金资助正文：The trial was initiated and planned by the researchers and funded by the Scientific Research Projects Unit of Chongqing Medical University (grant No. Project-cstc2016shms-ztzx13001). The study has no sponsor and was only supported by this public funding. The investigators received no fees from any industry.