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临床试验/NCT02912780
NCT02912780Unknown不适用

Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit - an Interprofessional Approach

McMaster Children's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Change of stress level of Parents - Salivary cortisol (ng/dL)

研究概览

简要总结

The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome.

Despite the growing knowledge around the need for reconstruction of large NICUs to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care.

A working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model.

The study was retrospectively registered.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change of stress level of Parents - Salivary cortisol (ng/dL)

时间窗: once every week, up to 3 month corrected age

Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)

时间窗: once every week, up to 3 month corrected age

Incidence of necrotizing enterocolitis

时间窗: up to 3 month corrected age

Number of days with parenteral nutrition

时间窗: up to 3 month corrected age

Bayley scale - Psychomotor Developmental Index

时间窗: up to 3 month corrected age

Number of changes in the primary health care professionals

时间窗: up to 3 month corrected age

Incidence of bronchopulmonary dysplasia

时间窗: up to 3 month corrected age

use of resources (lab tests, X-rays, microbiological tests)

时间窗: up to 3 month corrected age

number of procedures

Change of stress level of Patients - Salivary cortisol (ng/dL)

时间窗: once every week, up to 3 month corrected age

Length of stay - days

时间窗: up to 3 month corrected age

Incidence of sepsis

时间窗: up to 3 month corrected age

Time to full feed - days

时间窗: up to 3 month corrected age

Noise level (decibel)

时间窗: up to 3 month corrected age

Time of feed initiation - days

时间窗: up to 3 month corrected age

Bayley scale - Mental Developmental Index

时间窗: up to 3 month corrected age

Incidence of retinopathia of prematurity

时间窗: up to 3 month corrected age

Duration of mechanical ventilation - days

时间窗: up to 3 month corrected age

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Fusch

Professor

McMaster Children's Hospital

研究点 (1)

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