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Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT02912780
Recruitment Status : Unknown
Verified September 2016 by Christoph Fusch, McMaster Children's Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Christoph Fusch, 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.


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

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit - an Interprofessional Approach
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. Change of stress level of Health Care Professional - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
  2. Change of stress level of Parents - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
  3. Change of stress level of Patients - Salivary cortisol (ng/dL) [ Time Frame: once every week, up to 3 month corrected age ]
  4. Length of stay - days [ Time Frame: up to 3 month corrected age ]
  5. Incidence of necrotizing enterocolitis [ Time Frame: up to 3 month corrected age ]
  6. Incidence of retinopathia of prematurity [ Time Frame: up to 3 month corrected age ]
  7. Incidence of bronchopulmonary dysplasia [ Time Frame: up to 3 month corrected age ]
  8. Incidence of sepsis [ Time Frame: up to 3 month corrected age ]
  9. Duration of mechanical ventilation - days [ Time Frame: up to 3 month corrected age ]
  10. Time of feed initiation - days [ Time Frame: up to 3 month corrected age ]
  11. Time to full feed - days [ Time Frame: up to 3 month corrected age ]
  12. Number of days with parenteral nutrition [ Time Frame: up to 3 month corrected age ]
  13. Bayley scale - Psychomotor Developmental Index [ Time Frame: up to 3 month corrected age ]
  14. Bayley scale - Mental Developmental Index [ Time Frame: up to 3 month corrected age ]
  15. Number of changes in the primary health care professionals [ Time Frame: up to 3 month corrected age ]
  16. Noise level (decibel) [ Time Frame: up to 3 month corrected age ]
  17. use of resources (lab tests, X-rays, microbiological tests) [ Time Frame: up to 3 month corrected age ]
    number of procedures



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm and term infants
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912780


Contacts
Contact: Christoph Fusch, MD, PhD +1-905-527-6342 fusch@mcmaster.ca

Locations
Canada, Ontario
Faculty of Health Science, McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Christoph Fusch, MD, PhD    +1 905 521 2100 ext 75721    fusch@mcmaster.ca   
Principal Investigator: Christoph Fusch         
Sub-Investigator: Salhab el Helou         
Sub-Investigator: Samira Samiee-Zafarghandy         
Sub-Investigator: Gerhard Fusch         
Sub-Investigator: Muzafar Gani Abdul Wahab         
Sub-Investigator: Lynda Aliberti         
Sub-Investigator: Ahmad Bakry         
Sub-Investigator: Deborah Barnard         
Sub-Investigator: Joanne Doucette         
Sub-Investigator: Enas el Gouhary         
Sub-Investigator: Michael Marrin         
Sub-Investigator: Carrie-Lynn Meyer         
Sub-Investigator: Amit Mukerji         
Sub-Investigator: Anne Newbube         
Sub-Investigator: David Pogorzelski         
Sub-Investigator: Edward Pugh         
Sub-Investigator: Karen Schattauer         
Sub-Investigator: Jay Shah         
Sub-Investigator: Sandesh Shivananda         
Sub-Investigator: Sumesh Thomas         
Sub-Investigator: Jennifer Twiss         
Sub-Investigator: Connie Williams         
Sub-Investigator: Sourabh Dutta         
Sponsors and Collaborators
McMaster Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Fusch, Professor, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT02912780     History of Changes
Other Study ID Numbers: COHORT2013
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Lung Diseases
Inflammatory Bowel Diseases
Nutrition Disorders
Stress, Psychological
Neurodevelopmental Disorders
Infant Nutrition Disorders
Eye Manifestations
Pathologic Processes
Respiratory Tract Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Behavioral Symptoms
Mental Disorders
Eye Diseases
Signs and Symptoms