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临床试验/NCT03414671
NCT03414671已完成不适用

The Effect of Standardizing the Definition and Approach to a Clinically Significant Cardiopulmonary Event in Infants Less Than 30 Weeks on Length of Stay

Pediatrix1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pediatrix
入组人数
160
试验地点
1
主要终点
LOS - CSCPE

研究概览

简要总结

A health care initiative will be implemented December 4, 2017 in the Newborn Intensive Care (NICU) setting in an attempt to reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event (CSCPE). We would like to compare LOS in infants born < 30 weeks gestation before and after standardization to see if LOS is reduced.

详细描述

The LOS of infants born < 30 weeks prior to implementation of the standardized definition of a CSCPE (11/30/2015-11/30/2017) will be compared to the LOS for all infants who meet the inclusion criteria and born < 30 weeks from 6/1/2018 - 12/31/20. Data collection will begin June 1,2018, seven months after implementing the CSCPE definition. This will allow time for the nursing staff, the physicians and nurse practitioners to become familiar with the new CSCPE definition and management.

Following implementation of the new definition, the researchers will also do a 6 month audit on nursing response to a CSCPE based on the current alarm settings. Initially we do not plan to change the alarm limits but we may find the lower alarm limits for heart rate and oxygen saturation are set too high and may need to be lowered to more accurately assist nurses in recognizing when an infant is having a CSCPE. If the 6 month audit shows nurses are "missing" a CSCPE because the current lower alarm limits are set too high, or stimulating an infant inappropriately too early, the alarm limits will be changed at every bedside. If the alarm limits are reset, data collection will begin 6 months after the alarms are changed. This is expected to be starting 1/1/2019 and conclude 12/31/20. If it is decided the lower alarm limits will not need to be changed, data collection will begin 6/1/2018 and conclude 8/31/20 instead of 12/31/20.

研究设计

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

入排标准

年龄范围
23 Weeks 至 29 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All infants born < 30 weeks gestation admitted to the Swedish Hospital NICU from 11/30/2015-11/30/2017 (historical control, pre-standardized defined CSCPE) and 6/1/2018 - 12/31/20 (the group following implementation of the standardized defined CSCPE).

排除标准

  • Those babies who:
  • expired during the evaluation periods
  • transferred in after 30 weeks PMA
  • transferred out and then lost to follow-up
  • had a significant congenital, neurological, facial or airway anomaly affecting the infant's breathing beyond 36 weeks PCA
  • subjects who are not yet adults (infants, children, teenagers)

结局指标

主要结局

LOS - CSCPE

时间窗: 24 months

reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event

次要结局

未报告次要终点

研究者

发起方
Pediatrix
申办方类型
Other
责任方
Sponsor

研究点 (1)

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