Ni, Hsing-ChangHsing-ChangNiNI, HSING-CHANGHSING-CHANGNIYeh, Tsu F.Tsu F.YehWU-SHIUN HSIEHLiu, Hon-ManHon-ManLiuLIU, HON-MANHON-MANLIUChen, Chung M.Chung M.ChenTSENG, MEG MEI-CHIHMEG MEI-CHIHTSENGWu, Shou Y.Shou Y.WuTseng, Meg Mei-ChihMeg Mei-ChihTsengHusan, ZahidZahidHusanLi, Tsai C.Tsai C.LiHsieh, Wu S.Wu S.HsiehTsai, Chang H.Chang H.TsaiLin, Hung C.Hung C.Lin2018-09-102018-09-102016http://www.scopus.com/inward/record.url?eid=2-s2.0-84962916225&partnerID=MN8TOARShttp://scholars.lib.ntu.edu.tw/handle/123456789/399471Rationale: Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD. Objectives: To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD. Methods: A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ?50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control infants received surfactant only (100 mg/kg), until each infant required inspired O2 at less than 30% or was extubated. Measurements and Main Results: The intervention group had a significantly lower incidence of BPD or death (55 of 131 [42.0%] vs. 89 of 134 [66%]; risk ratio, 0.58; 95% confidence interval, 0.44-0.77; P<?0.001; number needed to treat, 4.1; 95% confidence interval, 2.8-7.8). The intervention group required significantly fewer doses of surfactant than did the control group. The intervention group had significantly lower interleukin levels (IL-1, IL-6, IL-8) in tracheal aspirates at 12 hours and lower IL-8 at 3-5 and 7-8 days. Conclusions: In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/ budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect.Bronchopulmonary dysplasia; Budesonide; Respiratory distress syndrome; Surfactant; Very-low-birth-weight infants[SDGs]SDG3beractant; budesonide; glucose; interleukin 1; interleukin 6; interleukin 8; surfactant; budesonide; lung surfactant; airway pressure; Apgar score; Article; artificial ventilation; bacteremia; blood pressure; body weight; brain hemorrhage; child; chorioamnionitis; comparative effectiveness; controlled study; cytokine response; disease severity; electrolyte blood level; female; follow up; glucose blood level; human; infant; lung dysplasia; major clinical study; male; multicenter study; necrotizing enterocolitis; neurologic examination; newborn; outcome assessment; oxygen supply; patent ductus arteriosus; physical examination; post hoc analysis; preschool child; priority journal; randomized controlled trial; respiratory distress syndrome; retrolental fibroplasia; sepsis; side effect; Taiwan; United States; very low birth weight; adverse effects; Bronchopulmonary Dysplasia; clinical trial; combination drug therapy; endotracheal intubation; mortality; procedures; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Budesonide; Drug Therapy, Combination; Female; Humans; Infant, Very Low Birth Weight; Intubation, Intratracheal; Male; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newbornjournal article10.1164/rccm.201505-0861OC