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Clinical Trials/NCT02912780
NCT02912780
Unknown
Not Applicable

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

McMaster Children's Hospital1 site in 1 country200 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
McMaster Children's Hospital
Enrollment
200
Locations
1
Primary Endpoint
Change of stress level of Parents - Salivary cortisol (ng/dL)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christoph Fusch

Professor

McMaster Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Health Care Professional - Salivary cortisol (ng/dL)

Time Frame: once every week, up to 3 month corrected age

Incidence of necrotizing enterocolitis

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

Number of changes in the primary health care professionals

Time Frame: up to 3 month corrected age

Incidence of bronchopulmonary dysplasia

Time Frame: up to 3 month corrected age

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

Time Frame: up to 3 month corrected age

number of procedures

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 sepsis

Time Frame: up to 3 month corrected age

Time to full feed - days

Time Frame: up to 3 month corrected age

Noise level (decibel)

Time Frame: up to 3 month corrected age

Time of feed initiation - days

Time Frame: up to 3 month corrected age

Bayley scale - Mental Developmental Index

Time Frame: up to 3 month corrected age

Incidence of retinopathia of prematurity

Time Frame: up to 3 month corrected age

Duration of mechanical ventilation - days

Time Frame: up to 3 month corrected age

Study Sites (1)

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