Clinical trial NCT02912780: Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit
Official title: Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit - an Interprofessional Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress, Psychological
Inflammatory Bowel Diseases
Lung Diseases
Infant Nutrition Disorders
Eye Manifestations
Neurodevelopmental Disorders
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm and term infants

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* no exclusion criteria

Primary outcomes:
measure: Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)
timeFrame: once every week, up to 3 month corrected age
measure: Change of stress level of Parents - Salivary cortisol (ng/dL)
timeFrame: once every week, up to 3 month corrected age
measure: Change of stress level of Patients - Salivary cortisol (ng/dL)
timeFrame: once every week, up to 3 month corrected age
measure: Length of stay - days
timeFrame: up to 3 month corrected age
measure: Incidence of necrotizing enterocolitis
timeFrame: up to 3 month corrected age
measure: Incidence of retinopathia of prematurity
timeFrame: up to 3 month corrected age
measure: Incidence of bronchopulmonary dysplasia
timeFrame: up to 3 month corrected age
measure: Incidence of sepsis
timeFrame: up to 3 month corrected age
measure: Duration of mechanical ventilation - days
timeFrame: up to 3 month corrected age
measure: Time of feed initiation - days
timeFrame: up to 3 month corrected age
measure: Time to full feed - days
timeFrame: up to 3 month corrected age
measure: Number of days with parenteral nutrition
timeFrame: up to 3 month corrected age
measure: Bayley scale - Psychomotor Developmental Index
timeFrame: up to 3 month corrected age
measure: Bayley scale - Mental Developmental Index
timeFrame: up to 3 month corrected age
measure: Number of changes in the primary health care professionals
timeFrame: up to 3 month corrected age
measure: Noise level (decibel)
timeFrame: up to 3 month corrected age
measure: use of resources (lab tests, X-rays, microbiological tests)
timeFrame: up to 3 month corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Faculty of Health Science, McMaster Children's Hospital
state: Ontario
Study officials:
References:
citation: El Helou S, Samiee-Zafarghandy S, Fusch G, Wahab MG, Aliberti L, Bakry A, Barnard D, Doucette J, El Gouhary E, Marrin M, Meyer CL, Mukerji A, Nwebube A, Pogorzelski D, Pugh E, Schattauer K, Shah J, Shivananda S, Thomas S, Twiss J, Williams C, Dutta S, Fusch C. Introduction of microsystems in a level 3 neonatal intensive care unit-an interprofessional approach. BMC Health Serv Res. 2017 Jan 21;17(1):61. doi: 10.1186/s12913-017-1989-6.