Department of Pediatrics, University of Lübeck, Lübeck, Germany.
Department of Neonatology, University of Cologne, Cologne, Germany.
Sci Rep. 2018 May 29;8(1):8333. doi: 10.1038/s41598-018-26437-x.
In a large cohort study of the German Neonatal Network (GNN) we aimed to evaluate whether less invasive surfactant administration (LISA) strategy is associated with complications of preterm birth. Within the observational period n = 7533 very-low-birth-weight infants (VLBWI) with gestational age 22 0/7 to 28 6/7 weeks were enrolled in GNN; n = 1214 VLBWI never received surfactant, n = 2624 VLBWI were treated according to LISA procedure, n = 3695 VLBWI had surfactant via endotracheal tube (ETT). LISA was associated with a reduced risk for adverse outcome measures including mortality [odds ratio (OR) 0.66 (95% CI: 0.51-0.84), p < 0.001] bronchopulmonary dysplasia [BPD; OR 0.55 (95% CI: 0.49-0.62), p < 0.001], intracerebral hemorrhage (ICH) grade II-IV [OR 0.55 (95% CI: 0.48-0.64), p < 0.001] and retinopathy of prematurity [ROP; OR 0.62 (95% CI: 0.45-0.85), p < 0.001]. Notably, LISA was associated with an increased risk for focal intestinal perforation [FIP; OR 1.49 (95% CI: 1.14-1.95), p = 0.002]. The differences in FIP rates were primarily observed in VLBWI born <26 weeks (LISA: 10.0 vs. ETT: 7.4%, p = 0.029). Our observational data confirm that LISA is associated with improved outcome. In infants <26 weeks we noted an increased risk for FIP. Future randomized controlled trials including LISA need to integrate safety analyses for this particular subgroup.
在德国新生儿网络(GNN)的一项大型队列研究中,我们旨在评估是否较少侵入性表面活性剂给药(LISA)策略与早产并发症有关。在观察期间,共有 7533 名胎龄为 22 0/7 至 28 6/7 周的极低出生体重儿(VLBWI)在 GNN 中登记;n=1214 名 VLBWI 从未接受过表面活性剂,n=2624 名 VLBWI 根据 LISA 程序进行治疗,n=3695 名 VLBWI 通过气管内管(ETT)给予表面活性剂。LISA 与不良结局指标的风险降低相关,包括死亡率[比值比(OR)0.66(95%CI:0.51-0.84),p<0.001]、支气管肺发育不良(BPD;OR 0.55(95%CI:0.49-0.62),p<0.001)、颅内出血(ICH)II-IV 级[OR 0.55(95%CI:0.48-0.64),p<0.001]和早产儿视网膜病变(ROP;OR 0.62(95%CI:0.45-0.85),p<0.001)。值得注意的是,LISA 与局灶性肠穿孔(FIP;OR 1.49(95%CI:1.14-1.95),p=0.002)的风险增加相关。FIP 发生率的差异主要见于胎龄<26 周的 VLBWI(LISA:10.0%与 ETT:7.4%,p=0.029)。我们的观察性数据证实,LISA 与改善结局相关。我们注意到在胎龄<26 周的婴儿中,FIP 的风险增加。未来包括 LISA 的随机对照试验需要为这一特定亚组纳入安全性分析。