Clinical Trial: Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:
Sponsor: McMaster Children's Hospital

Current Primary Outcome:

• Change of stress level of Health Care Professional - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
• Change of stress level of Parents - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
• Change of stress level of Patients - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
• Length of stay - days [ Time Frame: up to 3 month corrected age ]
• Incidence of necrotizing enterocolitis [ Time Frame: up to 3 month corrected age ]
• Incidence of retinopathia of prematurity [ Time Frame: up to 3 month corrected age ]
• Incidence of bronchopulmonary dysplasia [ Time Frame: up to 3 month corrected age ]
• Incidence of sepsis [ Time Frame: up to 3 month corrected age ]
• Duration of mechanical ventilation - days [ Time Frame: up to 3 month corrected age ]
• Time of feed initiation - days [ Time Frame: up to 3 month corrected age ]
• Time to full feed - days [ Time Frame: up to 3 month corrected age ]
• Number of days with parenteral nutrition [ Time Frame: up to 3 month corrected age ]
• Bayley scale - Psychomotor Developmental Index [ Time Frame: up to 3 month corrected age ]
• Bayley scale - Mental Developmental Index [ 
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: McMaster Children's Hospital
  

  Dates:
  Date Received: September 14, 2016
  Date Started: January 2013
  Date Completion: December 2017
  Last Updated: September 21, 2016
  Last Verified: September 2016