Siefkes Heather, Sunderji Sherzana, Vaughn Jessica, Sankaran Deepika, Vali Payam, Vadlaputi Pranjali, Timberline Sage, Bhatt Avni, Tancredi Daniel, Lakshminrusimha Satyan
Department of Pediatrics, University of California, Davis, Sacramento, CA 95817, USA.
School of Medicine, University of California, Davis, Sacramento, CA 95817, USA.
Children (Basel). 2022 Mar 11;9(3):396. doi: 10.3390/children9030396.
There are potential benefits and risks to the infant with higher and lower oxygen saturation (SpO) targets, and the ideal range for infants with pulmonary hypertension (PH) remains unknown. Targeting high SpO can promote pulmonary vasodilation but cause oxygen toxicity. Targeting lower SpO may increase pulmonary vascular resistance, especially in the presence of acidosis and hypothermia. We will conduct a randomized pilot trial to compare two ranges of target preductal SpO in late-preterm and term infants with hypoxic respiratory failure (HRF) and acute pulmonary hypertension (aPH) of the newborn. We will assess the reliability of a newly created HRF/PH score that could be used in larger trials. We will assess trial feasibility and obtain preliminary estimates of outcomes. Our primary hypothesis is that in neonates with PH and HRF, targeting preductal SpO of 95-99% (intervention) will result in lower pulmonary vascular resistance and pulmonary arterial pressures, and lower the need for pulmonary vasodilators (inhaled nitric oxide-iNO, milrinone and sildenafil) compared to targeting SpO at 91-95% (standard). We also speculate that a higher SpO target can potentially induce oxidative stress and decrease response to iNO (oxygenation and pulmonary vasodilation) for those patients that still require iNO in this range. We present considerations in planning this trial as well as some of the details of the protocol design (Clinicaltrials.gov (NCT04938167)).
对于血氧饱和度（SpO）目标较高和较低的婴儿，都存在潜在的益处和风险，而肺动脉高压（PH）婴儿的理想范围仍不清楚。将SpO目标设定较高可促进肺血管舒张，但会导致氧中毒。将SpO目标设定较低可能会增加肺血管阻力，尤其是在存在酸中毒和体温过低的情况下。我们将进行一项随机试点试验，比较晚期早产儿和足月儿患有新生儿缺氧性呼吸衰竭（HRF）和急性肺动脉高压（aPH）时，两个范围的导管前SpO目标。我们将评估一种新创建的HRF/PH评分在更大规模试验中使用的可靠性。我们将评估试验的可行性并获得结局的初步估计值。我们的主要假设是，对于患有PH和HRF的新生儿，将导管前SpO目标设定为95-99%（干预组）与设定为91-95%（标准组）相比，将导致更低的肺血管阻力和肺动脉压力，并减少对肺血管扩张剂（吸入一氧化氮-iNO、米力农和西地那非）的需求。我们还推测，对于在此范围内仍需要iNO的患者，较高的SpO目标可能会潜在地诱导氧化应激并降低对iNO的反应（氧合和肺血管舒张）。我们介绍了该试验规划中的考虑因素以及方案设计的一些细节（Clinicaltrials.gov（NCT04938167））。
