Department of Neonatology, Maternal and Child Health Hospital of Yongchuan, Chongqing, China.
Department of Neonatology, Chongqing Medical University Affiliated Children's Hospital, Chongqing, China.
BMJ Open. 2023 Mar 3;13(3):e068450. doi: 10.1136/bmjopen-2022-068450.
Tracheal intubation and invasive mechanical ventilation (IMV) significantly decreased mortality of respiratory distress syndrome (RDS) in extremely preterm infants (28 weeks' gestational age) whereas bronchopulmonary dysplasia increased. Thus, consensus guidelines recommend the use of non-invasive ventilation (NIV), as the preferred first-line approach for these infants. This trial aims to compare the effect of nasal continuous positive airway pressure (NCPAP) and non-invasive high-frequency oscillatory ventilation (NHFOV) as the primary respiratory support in extremely preterm infants with RDS.
We designed a multicentre, randomised, controlled, superiority trial investigating the effect of NCPAP and NHFOV as the primary respiratory support in extremely preterm infants with RDS in neonatal intensive units in China. At least 340 extremely preterm infants with RDS will be randomised to NHFOV or NCPAP as a primary mode of NIV. The primary outcomes will be the respiratory support failure determined by the need for IMV within 72 hours from birth.
Our protocol has been approved by the Ethics Committee of Children's Hospital of Chongqing Medical University. We will present our findings at national conferences and peer-reviewed paediatrics journals.
NCT05141435.
气管插管和有创机械通气（IMV）显著降低了极早产儿（28 周胎龄）呼吸窘迫综合征（RDS）的死亡率，而支气管肺发育不良的发生率增加。因此，共识指南建议使用无创通气（NIV），作为这些婴儿的首选一线治疗方法。本试验旨在比较鼻塞持续气道正压通气（NCPAP）和无创高频振荡通气（NHFOV）作为 RDS 极早产儿主要呼吸支持的效果。
我们设计了一项多中心、随机、对照、优效性试验，在中国新生儿重症监护病房（NICU）调查 NCPAP 和 NHFOV 作为 RDS 极早产儿主要呼吸支持的效果。至少 340 例 RDS 极早产儿将被随机分配到 NHFOV 或 NCPAP 作为 NIV 的主要模式。主要结局将是出生后 72 小时内需要 IMV 来确定呼吸支持失败。
我们的方案已经得到重庆医科大学儿童医院伦理委员会的批准。我们将在全国会议和同行评审的儿科期刊上展示我们的研究结果。
NCT05141435。
