Skip to content

Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912780
Enrollment
200
Registered
2016-09-23
Start date
2013-01-31
Completion date
2017-12-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Manifestations, Infant Nutrition Disorders, Inflammatory Bowel Diseases, Lung Diseases, Neurodevelopmental Disorders, Stress, Psychological

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.

Interventions

None listed

Sponsors

McMaster Children's Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All preterm and term infants admitted to McMaster Children's Hospital NICU

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Duration of mechanical ventilation - daysup to 3 month corrected age
Time of feed initiation - daysup to 3 month corrected age
Time to full feed - daysup to 3 month corrected age
Number of days with parenteral nutritionup to 3 month corrected age
Bayley scale - Psychomotor Developmental Indexup 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
Change of stress level of Parents - Salivary cortisol (ng/dL)once every week, up to 3 month corrected age
Change of stress level of Patients - Salivary cortisol (ng/dL)once every week, up to 3 month corrected age
Length of stay - daysup to 3 month corrected age
Incidence of necrotizing enterocolitisup to 3 month corrected age
Incidence of retinopathia of prematurityup to 3 month corrected age
Incidence of bronchopulmonary dysplasiaup to 3 month corrected age
Incidence of sepsisup to 3 month corrected age
Bayley scale - Mental Developmental Indexup to 3 month corrected age
Number of changes in the primary health care professionalsup to 3 month corrected age
Noise level (decibel)up to 3 month corrected age
use of resources (lab tests, X-rays, microbiological tests)up to 3 month corrected agenumber of procedures

Countries

Canada

Contacts

Primary ContactChristoph Fusch, MD, PhD
fusch@mcmaster.ca+1-905-527-6342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026