Department of Neonatology, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing, 400014, China.
Division of Pediatrics and Neonatal Critical Care, "A.Béclère" Medical Center, South Paris University Hospitals, AP-HP, Paris, France.
BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.
Various noninvasive respiratory support modalities are available in neonatal critical care in order to minimize invasive ventilation. Continuous positive airway pressure (CPAP) is the more commonly used but noninvasive positive pressure ventilation (NIPPV) seems more efficacious in the early post-extubation phase, although it is not clear if NIPPV may influence longterm outcomes. A recently introduced alternative is noninvasive high frequency oscillatory ventilation (NHFOV) which might be especially useful in babies needing high constant distending pressure. Preterm neonates may receive these respiratory supports for several weeks. Nonetheless, no data are available for the longterm use of NIPPV and NHFOV; few data exist on NHFOV and clinical outcomes, although its safety and suitability are reported in a number of preliminary short-term studies.
We designed an assessor-blinded, multicenter, three-arms, parallel, pragmatic, randomized, controlled trial with a superiority design, investigating the use of CPAP vs NIPPV vs NHFOV during the whole stay in neonatal intensive care units in China. Since safety data will also be analyzed it may be considered a phase II/III trial. Moreover, subgroup analyses will be performed on patients according to prespecified criteria based on physiopathology traits: these subgroup analyses should be considered preliminary. At least 1440 neonates are supposed to be enrolled. The trial has been designed with the collaboration of international colleagues expert in NHFOV, who will also perform an interim analysis at the about 50% of the enrolment.
The study is applying the best trial methodology to neonatal ventilation, a field where it is often difficult to do so for practical reasons. Nonetheless, ours is also a physiology-driven trial, since interventions are applied based on physiological perspective, in order to use ventilatory techniques at their best. The pragmatic design will increase generalizability of our results but subgroup analyses according to predefined physiopathological criteria are also previewed trying to have some advantages of an explanatory design. Since not all clinicians are well versed in all respiratory techniques, the training is pivotal. We intend to apply particular care to train the participating units: a specific 3-month period and several means have been dedicated to this end.
NCT03181958 (registered on June 9, 2017).
在新生儿重症监护中，有多种非侵入性呼吸支持方式可供选择，以尽量减少有创通气。持续气道正压通气（CPAP）是更常用的方法，但非侵入性正压通气（NIPPV）在拔管后早期似乎更有效，尽管尚不清楚 NIPPV 是否会影响长期结果。最近引入的替代方法是非侵入性高频振荡通气（NHFOV），它可能对需要高恒定膨胀压力的婴儿特别有用。早产儿可能需要接受这些呼吸支持数周。然而，目前尚无关于 NIPPV 和 NHFOV 长期使用的数据；关于 NHFOV 和临床结果的数据很少，尽管有许多初步的短期研究报告了其安全性和适用性。
我们设计了一项评估者盲法、多中心、三臂、平行、实用、随机、对照试验，设计为优效性试验，研究 CPAP 与 NIPPV 与 NHFOV 在整个中国新生儿重症监护病房住院期间的使用情况。由于也将分析安全性数据，因此它可以被认为是 II/III 期试验。此外，还将根据基于病理生理学特征的预设标准对患者进行亚组分析：这些亚组分析应被视为初步的。预计将纳入至少 1440 名新生儿。该试验是在 NHFOV 方面的国际专家合作下设计的，他们还将在大约 50%的入组时进行中期分析。
该研究应用了新生儿通气领域的最佳试验方法，这在实际操作中通常很难做到。然而，这也是一个基于生理学的试验，因为干预是根据生理学观点进行的，以便最大限度地利用通气技术。实用设计将增加我们研究结果的普遍性，但也预见到根据预先定义的病理生理学标准进行亚组分析，试图在解释性设计中具有一些优势。由于并非所有临床医生都精通所有呼吸技术，因此培训至关重要。我们打算特别注意培训参与单位：为此目的专门分配了特定的 3 个月时间和几种手段。
NCT03181958（2017 年 6 月 9 日注册）。
