Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

• Conditions: Stress, Psychological; Inflammatory Bowel Diseases; Eye Manifestations; Lung Diseases; Infant Nutrition Disorders; Neurodevelopmental Disorders

• Registration Number: NCT02912780
• Lead Sponsor: McMaster Children's Hospital

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 Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of stress level of Parents - Salivary cortisol (ng/dL)	once every week, up to 3 month corrected age
Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)	once every week, up to 3 month corrected age
Incidence of necrotizing enterocolitis	up to 3 month corrected age
Number of days with parenteral nutrition	up to 3 month corrected age
Bayley scale - Psychomotor Developmental Index	up to 3 month corrected age
Number of changes in the primary health care professionals	up to 3 month corrected age
Incidence of bronchopulmonary dysplasia	up to 3 month corrected age
use of resources (lab tests, X-rays, microbiological tests)	up to 3 month corrected age	number of procedures
Change of stress level of Patients - Salivary cortisol (ng/dL)	once every week, up to 3 month corrected age
Length of stay - days	up to 3 month corrected age
Incidence of sepsis	up to 3 month corrected age
Time to full feed - days	up to 3 month corrected age
Noise level (decibel)	up to 3 month corrected age
Time of feed initiation - days	up to 3 month corrected age
Bayley scale - Mental Developmental Index	up to 3 month corrected age
Incidence of retinopathia of prematurity	up to 3 month corrected age
Duration of mechanical ventilation - days	up to 3 month corrected age

Trial Locations

Locations (1)

Faculty of Health Science, McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada