Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02912780
• Other study ID #: COHORT2013
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2016
• Last updated: September 21, 2016
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: McMaster Children's Hospital
• Contact: Christoph Fusch, MD, PhD
• Phone: +1-905-527-6342
• Email: fusch[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• no exclusion criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Faculty of Health Science, McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of stress level of Health Care Professional - Salivary cortisol (ng/dL)		once every week, up to 3 month corrected age	No
Primary	Change of stress level of Parents - Salivary cortisol (ng/dL)		once every week, up to 3 month corrected age	No
Primary	Change of stress level of Patients - Salivary cortisol (ng/dL)		once every week, up to 3 month corrected age	No
Primary	Length of stay - days		up to 3 month corrected age	No
Primary	Incidence of necrotizing enterocolitis		up to 3 month corrected age	No
Primary	Incidence of retinopathia of prematurity		up to 3 month corrected age	No
Primary	Incidence of bronchopulmonary dysplasia		up to 3 month corrected age	No
Primary	Incidence of sepsis		up to 3 month corrected age	No
Primary	Duration of mechanical ventilation - days		up to 3 month corrected age	No
Primary	Time of feed initiation - days		up to 3 month corrected age	No
Primary	Time to full feed - days		up to 3 month corrected age	No
Primary	Number of days with parenteral nutrition		up to 3 month corrected age	No
Primary	Bayley scale - Psychomotor Developmental Index		up to 3 month corrected age	No
Primary	Bayley scale - Mental Developmental Index		up to 3 month corrected age	No
Primary	Number of changes in the primary health care professionals		up to 3 month corrected age	No
Primary	Noise level (decibel)		up to 3 month corrected age	No
Primary	use of resources (lab tests, X-rays, microbiological tests)	number of procedures	up to 3 month corrected age	No