Objective: To explore the feasibility and safety of minimally invasive surfactant administration (MISA) in preterm neonates with respiratory distress syndrome (NRDS). Methods: In this multicenter prospective randomized controlled trial, 92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1(st) July 2017 to 31(st) December 2018. They were randomly assigned to minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA) group according to random number generated by computer. Infants in both groups received calf pulmonary surfactant preparation at a dose of 70-100 mg/kg. The data of demography, perinatal situation, medication administration, complications, clinical outcomes in the two groups were compared with Chi-square test, Student's t-test, Mann-Whitney U test or Fisher's exact test. Results: Among the 92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males). The gestational age and birth weight were (29.5±1.2) weeks and (1 271±242) g in all patients, (29.5±1.4) weeks and (1 285±256) g in the MISA group, and (29.6±0.9) weeks and (1 255±227) g in the EISA group. The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s vs. 50 (30, 60) s, Z=3.009, P=0.003; 90 (60, 300) s vs. 60 (44, 270) s, Z=3.365, P=0.001). For the outcomes, the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD) were lower in the MISA group than in the EISA group (36% (17/47) vs. 67% (30/45), χ(2)=8.556, P=0.003; 26% (12/47) vs. 47% (21/45), χ(2)=4.464, P=0.035). Conclusions: Minimally invasive surfactant administration is applicable in preterm infants ≤30 weeks gestational age with NRDS. Although the length of whole procedure is longer than route endotracheal administration, the benefit of decreasing the incidences of hsPDA and BPD outweighs this demerit.
目的： 评价微创应用肺表面活性物质对早产儿呼吸窘迫综合征（NRDS）的疗效以及操作的可行性和安全性。 方法： 采用多中心前瞻性随机对照研究，以2017年7月1日至2018年12月31日京津冀地区8家三级医院新生儿重症监护病房出生胎龄≤30周考虑NRDS的患儿92例为研究对象。根据肺表面活性物质给药方式按计算机随机方法分为微创给药组和常规给药组，分别通过胃管或气管插管给予牛肺磷脂70~100 mg/kg。采用t检验、χ(2)检验、连续性校正χ(2)检验、Mann-Whitney U检验、Fisher精确检验对两组人口学信息、围生期情况、用药情况、合并症、临床转归等病例资料进行分析。 结果： 92例患儿中男53例、女39例，出生胎龄（29.5±1.2）周，出生体重（1 271±242) g。微创给药组47例，其中男25例，出生胎龄（29.5±1.4）周，出生体重（1 285±256)g；常规给药组45例，其中男28例，出生胎龄（29.6±0.9）周，出生体重（1 255±227）g。微创给药组的注药时间和总操作时间均长于常规给药组[60（18, 270）比50（30,60）s, 90（60，300）比60（44，270）s，Z=3.009、3.365，P=0.003、0.001]，微创给药组的有血液动力学影响的动脉导管未闭（hsPDA)、支气管肺发育不良（BPD）发生率均低于常规给药组[36%（17/47）比67%（30/45），26%（12/47）比47%（21/45），χ(2)=8.556、4.464，P=0.003、0.035]。 结论： 微创给药技术操作适用于出生胎龄≤30周的早产儿，虽有一定难度，操作时间明显长于气管插管给药，但是技术可行且与气管插管给药比较无不良影响，可降低hsPDA、BPD的发生率。.
Keywords: Minimally invasive; Pulmonary surfactant; Respiratory distress syndrome, newborn.