Efficacy of minimally invasive pulmonary surfactant administration in preterm infants with neonatal respiratory distress syndrome: a multicenter clinical trial
10.3760/cma.j.cn112140-20191018-00658
- VernacularTitle:微创应用肺表面活性物质治疗早产儿呼吸窘迫综合征的多中心临床研究
- Author:
Huiqiang LIU
1
;
Xiaomei TONG
;
Tongyan HAN
;
Hui ZHANG
;
Ming GUO
;
Xuefeng ZHANG
;
Xinjian LIU
;
Xiang ZHANG
;
Mingtao ZHANG
;
Fang LIU
;
Lisha BAO
;
Jun ZHENG
;
Xiuying TIAN
;
Qi GAO
;
Wanxian ZHANG
;
Yang DUAN
;
Fuqiang SUN
;
Wei GUO
;
Ling LI
;
Min XIAO
;
Weili LIU
;
Rui JIANG
Author Information
1. 北京大学第三医院儿科 100191
- Keywords:
Respiratory distress syndrome, newborn;
Pulmonary surfactant;
Minimally invasive
- From:
Chinese Journal of Pediatrics
2020;58(5):374-380
- CountryChina
- Language:Chinese
-
Abstract:
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.
