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首页> 外文期刊>Pediatric Research >Dose-escalation trial of budesonide in surfactant for prevention of bronchopulmonary dysplasia in extremely low gestational age high-risk newborns (SASSIE)
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Dose-escalation trial of budesonide in surfactant for prevention of bronchopulmonary dysplasia in extremely low gestational age high-risk newborns (SASSIE)

机译：表面活性剂在表面活性剂中的剂量升级试验，用于预防支气管扩张血管发育不良，在极低的胎龄高风险新生儿（Sassie）

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Initial trials of lung-targeted budesonide (0.25 mg/kg) in surfactant to prevent bronchopulmonary dysplasia (BPD) in premature infants have shown benefit; however, the optimal safe dose is unknown. Dose-escalation study of budesonide (0.025, 0.05, 0.10 mg/kg) in calfactatant in extremely low gestational age neonates (ELGANs) requiring intubation at 314 days. Tracheal aspirate (TA) cytokines, blood budesonide concentrations, and untargeted blood metabolomics were measured. Outcomes were compared with matched infants receiving surfactant in the Trial Of Late SURFactant (TOLSURF). Twenty-four infants with mean gestational age 25.0 weeks and 743 g birth weight requiring mechanical ventilation were enrolled at mean age 6 days. Budesonide was detected in the blood of all infants with a half-life of 3.4 h. Of 11 infants with elevated TA cytokine levels at baseline, treatment was associated with sustained decrease (mean 65%) at all three dosing levels. There were time- and dose-dependent decreases in blood cortisol concentrations and changes in total blood metabolites. Respiratory outcomes did not differ from the historic controls. Budesonide/surfactant had no clinical respiratory benefit at any dosing levels for intubated ELGANs. One-tenth the dose used in previous trials had minimal systemic metabolic effects and appeared effective for lung-targeted anti-inflammatory action.
机译：表面活性剂中肺靶向植物（0.25mg / kg）的初始试验，以防止过早婴儿的支气管扩张（BPD）的初始试验表明有益;然而，最佳安全剂量未知。在极低的妊娠期新生儿（ELGANs）在314天内，在极低的妊娠期新生儿（ELGANs）中的蛋白质（0.025,0.05,0.10mg / kg）的剂量 - 升级研究。测量气管吸汗（TA）细胞因子，血液预烯化浓度和未明确的血液代谢组。将结果与接受表面活性剂在后表面活性剂（Tolsurf）试验中的结果进行了比较。平均妊娠年龄的二十四个婴儿25.0周和743克的出生体重需要机械通气的平均年龄6天。在所有婴儿的血液中检测到预先培养3.4小时。在基线时11种具有升高的TA细胞因子水平的11个婴儿，在所有三种剂量水平下，治疗与持续减少（平均65％）相关。血皮质醇浓度的时间和剂量依赖性降低和总血液代谢物的变化。呼吸结果与历史控制没有差异。在管式ELGANS的任何剂量水平下，Budesonide /表面活性剂没有临床呼吸受益。先前试验中使用的剂量具有最小的全身代谢效应，并且对肺靶向抗炎作用有效。

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