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临床试验/NCT00486850
NCT00486850已完成4 期

Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress

University of Southern California8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
110
试验地点
8
主要终点
Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age

研究概览

简要总结

Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6 weeks gestation premature infants with respiratory distress treated with intratracheal Curosurf (poractant alpha) within 60 minutes of birth.

Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse events.

Number of Subjects: 110

详细描述

Respiratory management: SIMV group:

Infants randomized to SIMV will be maintained on SIMV per standard unit protocol. Infant can be progressively weaned and extubated to NCPAP if infant meets the minimum criteria for extubation. Caffeine will be administered around the time of extubation.

NIPPV group:

Extubated to NIPPV within 120 minutes of birth if the fraction of inspired oxygen (FiO2) is less than 0.60 after the first dose of surfactant. Caffeine will be administered around the time of extubation. Infant can be reintubated if clinical parameters necessitate mechanical ventilation. NIPPV may be discontinued when patients are weaned to a positive end expiratory pressure of 5 cmsH20 with back up rate <10 bpm and FiO2 <0.30 for 24 hours to nasal continuous positive airway pressure (NCPAP).

Surfactant administration:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Minutes 至 120 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Estimated gestational age 26 to 29 + 6 weeks inclusive;
  • Birth Weight: ≥ 600 grams;
  • Required endotracheal intubation for respiratory distress;
  • Has received one dose of poractant alfa 200mg/kg within 60 minutes of birth;
  • No known lethal congenital anomaly or genetic syndromes;
  • No known lung maturity; and
  • Signed parental informed consent

排除标准

  • Gestational age < 26 weeks or ≥ 30 weeks;
  • Birth weight less than 600 grams;
  • Apgar score of 0 at one minute of age; and
  • Lethal congenital anomaly or genetic syndrome identified antenatally or within 60 minutes of birth

结局指标

主要结局

Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age

时间窗: At 7 days of age

次要结局

  • Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age(At 7 days, 28 days and at 36 weeks postmenstraul age)

研究者

申办方类型
Other

研究点 (8)

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