A MULTICENTER RANDOMIZED TRIAL COMPARING 2 SURFACTANTS FOR THE TREATMENT OF NEONATAL RESPIRATORY-DISTRESS SYNDROME
A MULTICENTER RANDOMIZED TRIAL COMPARING 2 SURFACTANTS FOR THE TREATMENT OF NEONATAL RESPIRATORY-DISTRESS SYNDROME
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DOI：
10.1016/s0022-3476(05)80856-x
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发表时间：
1993-11-01
影响因子：
5.1
通讯作者：
GROSS, I
中科院分区：
文献类型：
--
作者：
HORBAR, JD;WRIGHT, LL;GROSS, I
目的：比较两种表面活性剂Exosurf Neonatal（Burroughs Wellcome Co.）关于Survanta设计：多中心随机试验。设置：参加国家儿童健康和人类发展研究所新生儿研究网络的11个三级护理大学新生儿重症监护室。患者：新生儿（n = 617），体重501 - 1500 gm，患有呼吸窘迫综合征，接受30%的辅助通气在1991年1月至1992年1月期间，纳入了出生后6小时内吸氧或吸氧以上的婴儿。干预措施：婴儿被随机分配接受多达4次的Exosurf Neonatal（n = 309）或Survanta（n = 308）腹膜内给药。主要结果测量：出生后28天死亡或支气管肺发育不良的发生率以及治疗后最初72小时内的平均吸入氧分数（FIO 2）和平均气道压（MAP）。
Objective: To compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.Design: Multicenter randomized trial.Setting: Eleven tertiary care university neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network.Patients: Newborn infants (n = 617) weighing 501 to 1500 gm with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992.Interventions: Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal (n = 309) or Survanta (n = 308).Main outcome measures: The occurrence of death or bronchopulmonary dysplasia 28 days after birth and the average fraction of inspired oxygen (FIO2) and mean airway pressure (MAP) during the first 72 hours after treatment.