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临床试验/NCT01601886
NCT01601886已完成不适用

Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial

Luc Brion1 个研究点 分布在 1 个国家目标入组 3,843 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,843
试验地点
1
主要终点
Endotracheal intubation in the delivery room

研究概览

简要总结

This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.

The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
24 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010

排除标准

  • Infants receiving comfort care
  • Those with major congenital anomalies
  • Those enrolled in the SUPPORT trial

结局指标

主要结局

Endotracheal intubation in the delivery room

时间窗: In the delivery room (1 day)

Frequency of endotracheal intubation in the delivery room

次要结局

  • Continuous positive airway pressure in the delivery room(In the delivery room (1 day))
  • Endotracheal intubation in the first four hours after admission(First four hours after admission)
  • Endotracheal intubation until four hours after admission(Between birth and 4 hours after admission)
  • Admninistration of surfactant(Any time between birth and 2 days of age)
  • Pneumothorax(Any time before discharge or transfer or 12 months of age (whichever comes first))
  • Bronchopulmonary dysplasia(28 days)
  • Necrotizing enterocolitis(Any time before discharge or transfer or 12 months of age (whichever comes first))
  • Duration of mechanical ventilation(Until discharge or transfer or 12 months of age (whichever comes first))
  • Maximum oxygen concentration(Until discharge or transfer or 12 months of age (whichever comes first))
  • Severe retinopathy of prematurity(Until discharge or transfer or 12 months of age (whichever comes first))
  • Mortality(Until discharge or transfer or 12 months of age (whichever comes first))
  • Severe brain lesion on imaging(Any time before discharge or transfer or 12 months of age (whichever comes first))

研究者

发起方
Luc Brion
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luc Brion

Professor of Pediatrics

University of Texas Southwestern Medical Center

研究点 (1)

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